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U.S. Department of Health and Human Services

Enforcement Report - Week of November 20, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes reduced 4898171 Class II Blood product, collected from a donor who tested reactive for the antibody to hepatitis B core antigen on two separate occasions, was distributed. Hemacare Corporation
Biologics Red Blood Cells Leukocytes Reduced 4040359 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Hemacare Corporation
Biologics Red Blood Cells Leukocytes Reduced 3520088 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Community Blood Bank, Inc.
Devices Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care List No. 11005; Serial Numbers: 16792201, 16792202, 16792205, 16792206, 16792208, 16792209, 16792210, 16792211, 16792213, 16792216, 16792217, 16792219, 16792220, 16792222, 16792223, 16792224, 16792225, 16792226, 16792227, 16792228, 16792230, 16792232, 16792233, 16792234, 16792235, 16792236, 16792238, 16792239, 16792240, 16792241, 16792242, 16792244, 16792245, 16792246, 16792248, 16792249, 16792250, 16792251, 16792252, 16792253, 16792254, 16792255, 16792256, 16792257, 16792258,  ...
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Class II Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack. Hospira Inc.
Devices Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report. Class II Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack. Hospira Inc.
Devices Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care List No. 11973; Serial Numbers: 12570148 , 12570150 , 12570154 , 12570163 , 12570170 , 12570177 , 12570204 , 12570211 , 12570212 , 12570255 , 12570270 , 12570319 , 12570359 , 12570385 , 12570413 , 12570425 , 12570455 , 12570487 , 12570662 , 12570695 , 12570854 , 12570915 , 12571080 , 12571243 , 12571437 , 12571631 , 12571692 , 12571776 , 12571826 , 12571835 , 12571837 , 12571842 , 12571877 , 12571880 , 12571886 , 12572317 , 12572369 , 12572586 , 12572909 , 12573547 , 12573567 , 12573837 , 12573990 , 12574424 , 12574501 , 12574524 , 12574556 , 12574599 , 12574619 , 12574731 , 12574749 , 12574853 , 12574858 , 12574860 , 12574865 , 12574961 , 12575626 , 12575698 , 12575886 , 12576125 , 12576443 , 12576485 , 12576518 , 12576593 , 12576609 , 12576710 , 12576722 , 12577271 , 12577685 , 12578856 , 12579183 Class II Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack. Hospira Inc.
Devices Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care List No. 12348; Serial Numbers: 13740156 , 13740256 , 13740266 , 13740351 , 13740380 , 13740451 , 13740508 , 13740612 , 13740632 , 13740731 , 13740732 , 13740733 , 13740734 , 13740735 , 13740736 , 13740737 , 13740738 , 13740739 , 13740740 , 13740741 , 13740742 , 13740743 , 13740744 , 13740745 , 13740746 , 13740747 , 13740748 , 13740749 , 13740750 , 13740751 , 13740752 , 13740753 , 13740754 , 13740755 , 13740756 , 13740757 , 13740758 , 13740759 , 13740760 , 13740761 , 13740762 , 13740763 , 13740764 , 13740765 , 13740766 , 13740767 , 13740768 , 13740769 , 13740770 , 13740771 , 13740772 , 13740773 , 13740774 , 13740775 , 13740776 , 13740777 , 13740778 , 13740779 , 13740780 , 13740781 , 13740782 , 13740783 , 13740784 , 13740785 , 13740786 , 13740787 , 13740788 , 13740789 , 13740790 , 13740791 , 13740792 , 13740793 , 13740794 , 13740795 , 13740796 , 13740797 , 13740798 , 13740799 , 13740800 , 13740801 , 13740802 , 13740803 , 13740804 , 13740805 , 13740806 , 13740807 , 13740808 , 13740809 , 13740810 , 13740811 , 13740812 , 13740813 , 13740814 , 13740815 , 13740816 , 13740818 , 13740819 , 13740820 , 13740821 , 13740822 , 13740823 , 13740824 , 13740825 , 13740826 , 13740827 , 13740828 , 13740829 , 13740830 , 13740831 , 13740832 , 13740833 , 13740834 , 13740835 , 13740836 , 13740837 , 13740838 , 13740839 , 13740840 , 13740841 , 13740842 , 13740843 , 13740844 , 13740845 , 13740846 , 13740847 , 13740848 , 13740849 , 13740850 , 13740851 , 13740852 , 13740853 , 13740854 , 13740855 , 13740856 , 13740857 , 13740858 , 13740859 , 13740860 , 13740861 , 13740862 , 13740863 , 13740864 , 13740865 , 13740866 , 13740867 , 13740868 , 13740869 , 13740870 , 13740871 , 13740872 , 13740873 , 13740874 , 13740875 , 13740876 , 13740877 , 13740878 , 13740879 , 13740880 , 13740881 , 13740882 , 13740883 , 13740884 , 13740885 , 13740886 , 13740887 , 13740888 , 13740889 , 13740890 , 13740891 , 13740892 , 13740893 , 13740894 , 13740895 , 13740896 , 13740897 , 13740898 , 13740899 , 13740900 , 13740901 , 13740902 , 13740903 , 13740904 , 13740905 , 13740906 , 13740907 , 13740908 , 13740909 , 13740910 , 13740911 , 13740912 , 13740913 , 13740914 , 13740915 , 13740916 , 13740917 , 13740918 , 13740919 , 13740920 , 13740921 , 13740922 , 13740923 , 13740924 , 13740925 , 13740926 , 13740927 , 13740928 , 13740929 , 13740930 , 13740977 , 13740980 , 13740982 , 13740986 , 13740994 , 13741025 Class II Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack. Hospira Inc.
Devices Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report. Class II Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack. Hospira Inc.
Devices Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report. Class II Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack. Hospira Inc.
Devices *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with Hospira MedNet Software; List Number: 20792; Labeled in part: PLUM A+; for use with Hospira MedNet; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report. Class II Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack. Hospira Inc.
Devices The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Hyperbaric Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. 1) List Number 11005; Serial Numbers: 16792201 , 16792202 , 16792205 , 16792206 , 16792208 , 16792209 , 16792210 , 16792211 , 16792213 , 16792216 , 16792217 , 16792219 , 16792220 , 16792222 , 16792223 , 16792224 , 16792225 , 16792226 , 16792227 , 16792228 , 16792230 , 16792232 , 16792233 , 16792234 , 16792235 , 16792236 , 16792238 , 16792239 , 16792240 , 16792241 , 16792242 , 16792244 , 16792245 , 16792246 , 16792248 , 16792249 , 16792250 , 16792251 , 16792252 , 16792253 , 16792254 , 16792255 , 16792256 , 16792257 , 16792258 , 16792259 , 16792260 , 16792261 , 16792263 , 16792264 , 16792265 , 16792266 , 16792268 , 16792269 , 16792271 , 16792272 , 16792273 , 18807402 , 18807405 , 18807406 , 18807407 , 18807408 , 18807409 , 18807410 , 18807413 , 18807414 , 18807417 , 18807418 , 18807420 , 18807421 , 18807423 , 18807427 , 18807428 , 18807429 , 18807430 , 18807431 , 18807432 , 18807433 , 18807434 , 18807439 , 18807443 , 18807444 , 18807446 , 18807449 , 18807452 , 18807453 , 18807455 , 18807456 , 18807459 , 18807463 , 18807466 , 18807472 , 18807474 , 18807478 , 18807484 , 18807485 , 18807486 , 18807490 , 18807491 , 18807494 , 18807496 , 18807499 , 18807500 , 18807501 , 18807506 , 18807509 , 18807510 , 18807511 , 18807513 , 18807514 , 18807518 , 18807523 , 18807524 , 18807529 , 18807535 , 18807536 , 18807539 , 18807540 , 18807541 , 18807542 , 18807543 , 18807545 , 18807546 , 18807556 , 18807557 , 18807568 , 18807574 , 18807575 , 18807576 , 18807578 , 18807581 , 18807584 , 18807585 , 18807586 , 18807588 , 18807589 , 18807590 , 18807591 , 18807596 , 18807597 , 18807598 , 18807599 , 18807600 , 18807601 , 18807602 , 18807604 , 18807605 , 18807607 , 18807608 , 18807609 , 18807610 , 18807611 , 18807612 , 18807613 , 18807614 , 18807617 , 18807618 , 18807619 , 18807620 , 18807623 , 18807625 , 18807626 , 18807627 , 18807628 , 18807630 , 18807631 , 18807632 , 18807633 , 18807634 , 18807636 , 18807637 , 18807639 , 18807640 , 18807695 , 18807696 , 18807697 , 18807698 , 18807699 , 18807700 Class II Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures. Hospira Inc.
Devices The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report. Class II Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures. Hospira Inc.
Devices The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. 1) List Number 11973; Serial Numbers: 12570148 , 12570150 , 12570154 , 12570163 , 12570170 , 12570177 , 12570204 , 12570211 , 12570212 , 12570255 , 12570270 , 12570319 , 12570359 , 12570385 , 12570413 , 12570425 , 12570455 , 12570487 , 12570662 , 12570695 , 12570854 , 12570915 , 12571080 , 12571243 , 12571437 , 12571631 , 12571692 , 12571776 , 12571826 , 12571835 , 12571837 , 12571842 , 12571877 , 12571880 , 12571886 , 12572317 , 12572369 , 12572586 , 12572909 , 12573547 , 12573567 , 12573837 , 12573990 , 12574424 , 12574501 , 12574524 , 12574556 , 12574599 , 12574619 , 12574731 , 12574749 , 12574853 , 12574858 , 12574860 , 12574865 , 12574961 , 12575626 , 12575698 , 12575886 , 12576125 , 12576443 , 12576485 , 12576518 , 12576593 , 12576609 , 12576710 , 12576722 , 12577271 , 12577685 , 12578856 , 12579183 Class II Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures. Hospira Inc.
Devices The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. 1) List Number 12348; Serial Numbers: 13740156 , 13740256 , 13740266 , 13740351 , 13740380 , 13740451 , 13740508 , 13740612 , 13740632 , 13740731 , 13740732 , 13740733 , 13740734 , 13740735 , 13740736 , 13740737 , 13740738 , 13740739 , 13740740 , 13740741 , 13740742 , 13740743 , 13740744 , 13740745 , 13740746 , 13740747 , 13740748 , 13740749 , 13740750 , 13740751 , 13740752 , 13740753 , 13740754 , 13740755 , 13740756 , 13740757 , 13740758 , 13740759 , 13740760 , 13740761 , 13740762 , 13740763 , 13740764 , 13740765 , 13740766 , 13740767 , 13740768 , 13740769 , 13740770 , 13740771 , 13740772 , 13740773 , 13740774 , 13740775 , 13740776 , 13740777 , 13740778 , 13740779 , 13740780 , 13740781 , 13740782 , 13740783 , 13740784 , 13740785 , 13740786 , 13740787 , 13740788 , 13740789 , 13740790 , 13740791 , 13740792 , 13740793 , 13740794 , 13740795 , 13740796 , 13740797 , 13740798 , 13740799 , 13740800 , 13740801 , 13740802 , 13740803 , 13740804 , 13740805 , 13740806 , 13740807 , 13740808 , 13740809 , 13740810 , 13740811 , 13740812 , 13740813 , 13740814 , 13740815 , 13740816 , 13740818 , 13740819 , 13740820 , 13740821 , 13740822 , 13740823 , 13740824 , 13740825 , 13740826 , 13740827 , 13740828 , 13740829 , 13740830 , 13740831 , 13740832 , 13740833 , 13740834 , 13740835 , 13740836 , 13740837 , 13740838 , 13740839 , 13740840 , 13740841 , 13740842 , 13740843 , 13740844 , 13740845 , 13740846 , 13740847 , 13740848 , 13740849 , 13740850 , 13740851 , 13740852 , 13740853 , 13740854 , 13740855 , 13740856 , 13740857 , 13740858 , 13740859 , 13740860 , 13740861 , 13740862 , 13740863 , 13740864 , 13740865 , 13740866 , 13740867 , 13740868 , 13740869 , 13740870 , 13740871 , 13740872 , 13740873 , 13740874 , 13740875 , 13740876 , 13740877 , 13740878 , 13740879 , 13740880 , 13740881 , 13740882 , 13740883 , 13740884 , 13740885 , 13740886 , 13740887 , 13740888 , 13740889 , 13740890 , 13740891 , 13740892 , 13740893 , 13740894 , 13740895 , 13740896 , 13740897 , 13740898 , 13740899 , 13740900 , 13740901 , 13740902 , 13740903 , 13740904 , 13740905 , 13740906 , 13740907 , 13740908 , 13740909 , 13740910 , 13740911 , 13740912 , 13740913 , 13740914 , 13740915 , 13740916 , 13740917 , 13740918 , 13740919 , 13740920 , 13740921 , 13740922 , 13740923 , 13740924 , 13740925 , 13740926 , 13740927 , 13740928 , 13740929 , 13740930 , 13740977 , 13740980 , 13740982 , 13740986 , 13740994 , 13741025 Class II Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures. Hospira Inc.
Devices The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report. Class II Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures. Hospira Inc.
Devices The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report. Class II Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures. Hospira Inc.
Devices The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report. Class II Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures. Hospira Inc.
Devices The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report. Class II Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken distal pressure pin could result in incorrect distal pressure readings, undetected distal occlusions and/or undetected cassette failures. Hospira Inc.
Biologics Red Blood Cells Leukocytes Reduced W036812590578; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced Irradiated W036812853051; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W036812590578; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W047013208805; W047013208805; Class III Blood products, held in quarantine pending results of an investigation, were distributed. New York Blood Center, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W067113705080; Class II Blood product, manufactured from an apheresis unit with insufficient platelet yield for the unit to be split, was distributed. The Blood Center
Biologics Fresh Frozen Plasma (Apheresis) W067113704370; Class II Donor Screening/Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to history. The Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W067113704370; Class II Blood products, collected from a donor who had been temporarily deferred, were distributed. The Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W067113704370; Class II Donor Screening/Deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to history. The Blood Center
Biologics Fresh Frozen Plasma W120613000269; Class II Blood product, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), was distributed. Michigan Blood
Food PRIESTER'S PECANS brand brand ROASTED SALTED PISTACHIOS, item #18010, Net Wt. 1 lb (454g), UPC 720056180104; item #15502, Net Wt. 8 oz (226.8g), UPC 001001155027; Stock No. 189, Net Wt. 2 lb (907g) The product is not coded. Class I Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella. Priester Pecan Company, Inc.
Food PRIESTER'S PECANS brand NUTTY FAVORITES ASST, Stock No. 79, Net Wt 1 lb 10 oz (737g) The product is not coded. Class I Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella. Priester Pecan Company, Inc.
Food PRIESTER'S PECANS brand FANCY ROASTED NUTS, Stock No. 7, Net Wt 12 oz (454g) The product is not coded. Class I Pistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella. Priester Pecan Company, Inc.
Biologics Red Blood Cells W036812560746; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Fresh Frozen Plasma W036812560746; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Platelets Pooled Leukocytes Reduced W036812859472; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells Leukocytes Reduced W051513054232; Class II Blood products, exposed to unacceptable shipping temperatures, were distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced Irradiated W051513058139; W051513060745; W051513060748; W051513068170; Class II Blood products, exposed to unacceptable shipping temperatures, were distributed. Innovative Blood Resources
Biologics Red Blood Cells W051513051659; W051513053101; W051513057298; W051513057299; W051513057300; W051513057301; W051513057303; W051513057315; W051513057316; W051513054782; W051513058923; Class II Blood products, exposed to unacceptable shipping temperatures, were distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced Irradiated W051512082767; W051510117188; Class III Blood products, collected from donors who were at risk for Leishmaniasis, were distributed. Innovative Blood Resources
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W051511030045; W051511030045; W051510132288; W051510132288; W051512114636; W051512114636; W051511062344; W051511062344; Class III Blood products, collected from donors who were at risk for Leishmaniasis, were distributed. Innovative Blood Resources
Biologics Red Blood Cells W051512104124; W051512009908; W051512103272; W051512096107; W051512051693; W051511053775; Class III Blood products, collected from donors who were at risk for Leishmaniasis, were distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced W051511041885; W051512111200; W051512103106; W051513003287; W051512075299; W051511060759; W051511042906; W051511017113; W051511013800; W051512094805; W051512146430; W051512108531; W051512108488; W051512000140; W051512044707; W051512031408; W051511127473; W051511004168; W051511074771; W051511074402; Class III Blood products, collected from donors who were at risk for Leishmaniasis, were distributed. Innovative Blood Resources
Biologics Platelets Pheresis Leukocytes Reduced W041513016488W; Class III Blood product, labeled with the incorrect platelet count and product volume, was distributed. Blood Systems, Inc. dba United Blood Services Texas
Biologics Platelets Pheresis Leukocytes Reduced W115113138063X; Class II Blood product, with no documentation of monthly QC testing for pH, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Platelets Pheresis Leukocytes Reduced W115113151800A; W115113151800A; Class II Blood products, which did not meet QC specifications for platelet pH, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Platelets Pheresis W1151131631751; W1151131631751; W1151131631751; Class II Blood products, with platelet counts below the specified minimum requirement, were distributed. Lifesouth Community Blood Centers - Montgomery Region
Biologics Platelets Pheresis Leukocytes Reduced W115113136973Q; W115113136973Q; W115113136973Q; Class II Blood products, with platelet counts below the specified minimum requirement, were distributed. Lifesouth Community Blood Centers - Montgomery Region
Biologics Platelets Pheresis Leukocytes Reduced W1151131209912; Class II Blood product, with platelet count below the specified minimum requirement, was distributed. Lifesouth Community Blood Centers - Montgomery Region
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W040713692503; W040713692503; W040713443772; W040713211379; W040713443792; W040713614024; W040713444328; W040713444328; W040713211403; W040713211403; W040713462890; W040713462917; W040713462926; W040713602263; W040713211672; W040713693099; W040713213007; W040713463015; W040713456715; W040713456715; W040713602387; W040713211251; W040713614094; W040713692560; W040713692560; Class II Blood products, with disparate weights between the two units collected during the apheresis procedure, were distributed. Indiana Blood Center
Biologics Red Blood Cells Leukocytes Reduced W071913002143; Class II Blood product, not appropriately labeled as a low volume unit, was distributed. So Ca Permamente Med Group Blood Donor Cntr
Devices 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. All lot codes Class II Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss Fresenius Medical Care Holdings, Inc.
Devices Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. All lot codes Class II Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss Fresenius Medical Care Holdings, Inc.
Devices Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. All lot codes Class II Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss Fresenius Medical Care Holdings, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 13X56755; 13X56755; Class II Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed. American National Red Cross Southeastern Michigan Region
Devices S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field. Part Number/Lot Number: 11-50109 43092R; 11-50109 46415; 11-50109 CT12H013; 11 -50109-1 46415-1; 11-50110 43089; 11-50110 43089R; 11-50110 46416; 11-50110-1 46416-1 Class II Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades. SpineFrontier, Inc.
Devices Siemens syngo.plaza image processing system image processing radiological system Model Number 10592457 with serial numbers 100263, 100177, 100138, 100174, 100005, 100006, 100007, 100008, 100009, 100010, 100219, 100201, 100198, 100181, 100249, 100301, 100302, 100157, 100146 Class II The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems. Siemens Medical Solutions USA, Inc
Devices Artis zee systems x-ray, angiographic system model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot Class II The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur. Siemens Medical Solutions USA, Inc
Devices Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone. part numbers 19-0005 Class II Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of the currently cleared indications for use fo the device(s). The currently cleared indications for use for the pnuematic and electric motor systems is "cutting and shaping bone". The Anspach Effort, Inc.
Devices Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone part number 20-0019 Class II Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of the currently cleared indications for use fo the device(s). The currently cleared indications for use for the pnuematic and electric motor systems is "cutting and shaping bone". The Anspach Effort, Inc.
Devices Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone. part number 20-0020 Class II Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of the currently cleared indications for use fo the device(s). The currently cleared indications for use for the pnuematic and electric motor systems is "cutting and shaping bone". The Anspach Effort, Inc.
Food US Pistachio Shelled, Halves, Raw, Net Weight: 30lbs. Lot#TO010092, expiry date: September 2014 Class I Primex International Trading Corp. is recalling Pistachios Shelled, Halves, because it has the potential to be contaminated with Salmonella. Primex Intl Trading Corp
Biologics Cornea 20130169CNOD; 20130169CNOS Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions VisionGift
Biologics Cornea 2011251C; 2011252C Class II Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2011293C; 2011294C Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2011366C; 2011365C Class II Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2011344C Class III Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. Lions Eye Bank For Long Island
Biologics Cornea 2011321C; 2011322C Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Bank For Long Island
Devices SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids. Product Code: 35700BAX, 35700ABB Serial Numbers: All Class II Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions. Baxter Healthcare Corp.
Devices DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS® Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Intermediary Tubing is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy . All lots with a D identifier Class II Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS® Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy. All lot codes Class II Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination DePuy Mitek, Inc., a Johnson & Johnson Co.
Biologics Cornea 2011348C Class III Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. Lions Eye Bank For Long Island
Biologics Cornea 2011335C; 2011336C Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2009275C; 2009276C Class II Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Bank For Long Island
Devices VerSys® Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty. 00369673 00369898 00369984 00369985 00369988 00369989 00369995 00369996 00369997 00369998 00370074 00370082 00370103 00370161 00370162 00370163 00370165 00370166 00370240 00370241 00370242 00370244 00370245 00370246 00370285 00370299 00370300 00370301 00370371 00370374 00370376 00370377 00370378 00370379 00370382 00370405 00370406 00370407 00370409 00370411 00370417 00370428 00370471 00370475 00370620 00370621 00370906 60486158 60495799 60495801  ...
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Class II Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing (seal integrity and seal strength) to provide a 90% confidence and 99% reliability were not available for testing. As a result, Zimmer is recalling all lots of the product due to the potential that the sterile barrier integrity may be compromised. Zimmer, Inc.
Food GoPicnic Black Bean Dip & Plantain Chips; ready-to-eat meal kit with professor zim zam's extraordinary sweets dark chocolate with orange packaged in paperboard container; NET WT 4.2 OZ (116.2g); distributed by gopicnic brands, inc.; chicago, il 60613; www.gopicnic.com; GoPicnic Black Bean Dip & Plantain Chip Meal; Lot Code and Best By Date: 10773, 10/15/13(1872); 10773, 10/16/13(1782); 10773, 10/8/13(11664); 10773, 8/16/13(5274); 11063, 1/28/14(774); 11063, 10/8/13(12708); 11063, 2/11/14(5832); M13107, 3/5/2014; M23107, 3/5/2014; M13137, 3/5/14(2736); M13137, 3/6/14(5616); M23137, 3/5/14(1692); M23137, 3/6/14(2004); M13165, 3/14/2014; M13175, 3/14/14(4986); M13175, 3/5/14(444); M13175, 5/6/14(3942); M13182, 4/8/14(1872); M13182, 5/19/14(876); M23182,  ...
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Class I The chocolates included in the meal kits may contain undeclared milk allergens. GoPicnic, Inc.
Food Gopicnic; Hummus & crackers; GoPicnic meal kit packaged in paperboard container. ready-to-eat meal; with professor zim zam's extraordinary sweets dark chocolate with sea salt. NET WT 4.1 OZ (116g); distributed by gopicnic brands, inc.; chicago, il 60613; www.gopicnic.com GoPicnic Hummus & Crackers Meal; Lot Code and Best By Date: 10303, 9/24/2013; 10373, 9/26/2013; 10383, 9/26/2013; 10503, 10/29/13(7986); 10503, 11/12/13(8148); 10503, 11/13/13(5616); 10513, 11/13/13(13584); 10513, 12/3/13(9684); 10523, 12/3/2013; 10623, 12/3/2013; 10663, 12/4/2013; 10793, 125/13(3744); 10793, 12/8/13(24948); 10803, 12/5/2013; 10923, 12/6/13(13104); 10923, 12/19/13(7488); M13106, 12/19/13(3102); M13106, 12/29/13(15882); 11063, 12/19/13(6732); 11063,  ...
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Class I The chocolates included in the meal kits may contain undeclared milk allergens. GoPicnic, Inc.
Devices Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1975903 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1013226 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1308519 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1530633 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1467067 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1405794 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; Virtual Access Software, StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1301761 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; Virtual Access Pluse SW, StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1337195 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8171837 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8230633 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1097229 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8380354 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8648503 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1673334 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8656456 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1149418 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1560713 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8976268 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1645324 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8768178 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8978504 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1384700 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8891640 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8678468 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8101768 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1630185 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1961382 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1549377 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 848164 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8215956 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8485021 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8711459 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8485021 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8711459 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8859811 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 886578 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1482116 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8274888 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8062374 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8446361 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1849592 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8203101 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8795866 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1387042 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1618198 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1738905 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1981042 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8296642 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8441602 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8553331 Class II Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem. Carestream Health Inc.
Devices SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. Product Code: 35700BAX & 35700ABB; Serial Numbers: 433713, 435563, 704056, 707290, 715315, 724216, 740127, 752318, 752447, 753675, 754947, 759766, 765934, 770034, 772017, 773470, 776507, 781016, 781969, 783352, 783454, 787567, 789720, 791225, 794828, 794990, 797185, 804798, 808393, 808764, 810971, 812076, 818718, 821213, 824067, 824198, 839143, 850028, 850577, 852007, 852431, 855450, 860201,  ...
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Class II Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge. Baxter Healthcare Corp.
Devices Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Serial Numbers: 508801, 508802, 508803, 508804, 508805, 508806, 508807, 508810 Class II Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage. Beckman Coulter Inc.
Food Dannon LIGHT & FIT® Nonfat Yogurt - 4 PACK of 6 oz cups. Vanilla UPC 36632 02721 Expiration code OCT 27 2013 WE Class II Dannon Company, Inc. is recalling Light n Fit Nonfat Yogurt because they may contain yeast. The Dannon Company, Inc.
Food Dannon LIGHT & FIT® Nonfat Yogurt - 4 PACK of 6 oz cups. Peach UPC 36632 02722. Expiration code OCT 27 2013 WE Class II Dannon Company, Inc. is recalling Light n Fit Nonfat Yogurt because they may contain yeast. The Dannon Company, Inc.
Food Dannon LIGHT & FIT® Nonfat Yogurt - 4 PACK of 6 oz cups. Strawberry UPC 36632 02720. Expiration code OCT 27 2013 WE Class II Dannon Company, Inc. is recalling Light n Fit Nonfat Yogurt because they may contain yeast. The Dannon Company, Inc.
Food Dannon LIGHT & FIT® Nonfat Yogurt - 4 PACK of 6 oz cups. Strawberry/Banana UPC 36632 02181. Expiration code OCT 27 2013 WE Class II Dannon Company, Inc. is recalling Light n Fit Nonfat Yogurt because they may contain yeast. The Dannon Company, Inc.
Food Dannon LIGHT & FIT® Nonfat Yogurt - 4 PACK of 6 oz cups. Cherry UPC 36632 02180. Expiration code OCT 27 2013 WE Class II Dannon Company, Inc. is recallingLight n Fit Nonfat Yogurt because they may contain yeast. The Dannon Company, Inc.
Food Dannon LIGHT & FIT® Nonfat Yogurt - 4 PACK of 6 oz cups. Blueberry UPC 36632 02723. Expiration code OCT 27 2013 WE Class II Dannon Company, Inc. is recalling Light n Fit Nonfat Yogurt because they may contain yeast. The Dannon Company, Inc.
Food Apotheca Energique Gastrozyme, dietary supplement, 100 vegetarian capsules. Lot number C3354 The product mathmatical analysis of potential Chloramphenicol level is 1.07 ppb. Class II The products may contain chloramphenicol. Grato Inc.
Devices Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded. Part number: 0206-522-000 and lots: 08183012, 08310012, 09237012, 10243012, 11109012, 11353012, and 12216012 Class II On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15, 2013, when the product was going to be placed in the pouch to be sealed, the manufacturing operator noticed that some assemblies were cracked. As a result of the injection pressure of the cement gun, a cracked tiplet may release from the Hub during cement application. There is also the potential for cement to leak out from the fissure in the tiplet during setting time, resulting in an inadequate supply of cement required to complete the surgery. Stryker Instruments Div. of Stryker Corporation
Devices Composite Series Skull Clamp, one clamp per tote. The MAYFIELD® Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary The following serial numbers are affected by this recall: SS120076, SS120082, SS120083, SS120084, SS120088, SS120089, SS120090, SS120092, SS120093, SS120094, SS120095, SS120111, SS120112, SS120113, SS120114, SS120115, SS120116, SS120117, SS120118, SS120119, SS120120, SS120121, SS120122, SS120123, SS120124, SS120125, SS120126, SS120127, SS120128, SS120130, SS120131, SS120133, SS120134, SS120135, SS120171, SS120252, SS120256, SS120257 Class II An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. None of the complaints resulted in a report of patient injury, adverse health consequence, or a delay / prolongation of the surgical procedure. Integra LifeSciences Corp.
Devices 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system. Part Number:. 00-0903-2634 and lot number 009U2 Class II The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics. OrthoPediatrics Corp
Devices Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257 Class II Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material. Synthes USA HQ, Inc.
Food Cellulase: ACTA 4-702 APEX 17-6262 APEX 6-9762 ARTH EB 10831 BETA GLUCANASE 1000 BROOK 8-352 CELLULASE 1000 CELLULASE 4000 CELLULASE CONC. CENTURY 7-152 CLENZSEB DIGESEB DIGESEB PB DIGESEB PLUS DIGESEB PLUS 401 DIGESEB SUPER DIGESEB SUPER 118 EB 10-14081 EB 10-15351 EB 12-706 EB 14-14201 EB 16-15612 EB 17-14161 EB 5-13302 EB 5-14121 EB 5-15361 EB 8-15731 EB 9-14181 EB 9-14191 EL 5-7212 GLOBAL 8-658 GREENZYME 427 HEMISEB JARL 3-164 NAT 9-185 NF 525 NHK 14-9451 NPC 270 NPC 5005 NPC 6006 NW 7B 9142 PB 10401 SEB GLUTEN RELIEF SEB GLUTEN RELIEF HNS SUPER 108 TUMMYEASE VEGPANZYME PLUS VR 5-8451 Lot Numbers: 3051077 3031052; 3061042 3041028 3041002 3031048 3041011 3041032 3031046 3021019 3021026; 3021053 3071063 3031064 3051045 3041039; 3031054 3031038 3031051 3021067; 3061049 3041012 3021073; 3031017 3071054 3041020 3081005 3021074; 3071059 3071007 3021048; 3041047 3021072; 3031016 3051028 3041021 3031033 3081009 3021015; 3021016 3041057 3051027; 3061019; 3071046; 3031063 3031058 3031022; 3041085 3071071; 3071072 3041055 3021032; 3021033; 3051089 3021022 3021035 3021066 3021041; 3031072; 3031073; 3021039 3021042 3041014; 3041058 3031047 3031018 3031025 3031021; 3041045 Class II Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol. Specialty Enzymes & Biotechnologies
Food Protease: APEX 10-7082 CENTURY 7-152 EB 2-14511 EB 5-16901 EB 8-14861 EB 9-14191 EXCLZYME EXCLZYME EN GLOBAL 8-658 HFN 7-7113 META 10-185 MHNHEM 2-158 PEPZYME AG PROTEASE - 1000 PROTEASE 250,000 SEB PRO FP 500 SEB PRO FP 600 SYS 7-7742 UT 11-216 N VEGPANZYME 1213 VEGPANZYME PLUS Lot Numbers: 3071023 3071011 3071039 3061013 3051087 3071034 3031065 3031065 3051054; 3071020; 3061004 3071038 3061033 3061014 3051022; 3061041; 3071070; 3051092; 3071001 3051084; 3071060 3051038 3041051; 3071040 3061025 3071029 3051052 3071027 3071005 Class II Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol. Specialty Enzymes & Biotechnologies
Food Cellulase & Protease: APEX 10-639 A DIGESEB DIGESEB PLUS DIGESEB SUPER EB 10-14171 EB 10-16192 EB 12-11331 EB 12-9205 EB 14-14201 EB 15-13662 EB 18-13081 EB 7-12831 EB 7-12901 EB 7-14211 EB 8-15731 EL 5-7212 ENZIGEST N FIZYME # 1209 N GLOBAL 8-658 HERB 10-6973 HFI 4-7601 HFN 7-7113 META 10-185 NB 6-7812 NF 525 NHK 14-9451 NPC 7007 NPC 8008 NUTRO 8-7961 OHS - 9804 PROTHERA 18-9724 PROTHERA 19-9723 PROTHERA 8-12182 SD 7-581 SEB GLUTEN RELIEF SEB GLUTEN RELIEF HNS UT 11-216 N VEGPANZYME 1213 VEGPANZYME 1X VEGPANZYME PLUS VT 11-693 Lot Numbers: 3071056 3051069 3061036 3041059; 3061050 3061040 3071014; 3071015 3061044 3051009 3051042 3061058 3041089 3031082 3041038 3041024 3061043 3051040 3061062 3031029; 3061047; 3061048; 3041030 3031050; 3031080; 3031081 3071002 3041013; 3051091 3041037; 3041054 3031028; 3041031 3041073 3041025; 3041026; 3041027; 3061060 3081004 3031034 3031055 3041007 3071045; 3061034 3031066 3051043; 3071006 3051007 3041056; 3061026 3031053 3041064 3051050; 3051056 3031049; 3041034 3061054 3071025; 3071026 3041084 3071012 Class II Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol. Specialty Enzymes & Biotechnologies
Food Papain: NF 4-608 B NF 4-6152 NUTRA 6-452 PAPAIN PROHYDROXY NF 4-714 Lot Numbers: 3061056 3071003 3071021 3070018 3061057 Class II Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol. Specialty Enzymes & Biotechnologies
Food XYLANASE 150,000 Lot Numbers: 3041043 Class II Specialty Enzymes and Biotechnologies is recalling cellulase/mannanase and fungal protease because they may contain low levels of chloramphenicol. Specialty Enzymes & Biotechnologies
Devices Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. all serial numbers Class II Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR). Medtronic Neuromodulation
Devices Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. all serial numbers Class II Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR). Medtronic Neuromodulation
Food WELLTRIENTS DIGESTAIDS FORMULA #2, 90 capsules per bottle. Item #61256-90 Lot#17061 Class II Creation's Garden Natural Products (CGNP) is recalling Welltrients Digestaids Formula #2 because it has been found to contain chloramphenicol. Creation's Garden Natural Products Inc
Food Digestive Health, 90 vegetable capsules Lot numbers: 3021204 & 3061303 Class II Ultra Laboratories is recalling Digestive Health because a raw material used in its formulation may have been contaminated with chloramphenicol. Ultra Laboratories
Food Spectrazyme, 180 count, 60 count, 12 bottles/case, 20000 tablets/box, 14000 capsules/pail. Lot Code: 0413083 0513007 0513008 Class II Metagenics is recalling Spectrazyme because their raw material supplier informed them that enzymes in the blend may contain the antibiotic chloramphenicol. Metagenics, Inc.
Devices Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care Catalog numbers:MZ00614, MZ01038, MZ02190, MZ02254, and MZ02332 Class II Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive screw in the motor unit broke and the lift arm fell down approximately 60 cm (23.6 inches). Draeger Medical, Inc.
Devices Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices. Batch 1041070019 1041080059 1041080056 1041080058 1041080055 1041080064 1041080063 1041080057 1041080060 1041070023 1041070022 1041080069 1041080070 1041080066 1041080068 1041080072 1041080073 1041080082 1041080077 1041080061 1041080074 1041080076 1041080078 1041080079 1041080081 1041080087 1041080071 1041080093 1041080080 1041080095 1041080090 1041080089 1041080088 1041080097 1041080098 1041080091 1041080099 1041080100 1041080101 1041080096 1041080159 1041080103 1041080102 1041080104 1041080160 1041080167 1041080172 1041080168 1041080169  ...
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Class II Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps. Advanced Sterilization Products
Devices AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. 006 00000Q13022004 00000G10271002 00000G10271001 00000F10281001 0000AC12277003 0000AC12277001 00000M13123012 00000J13175001 00000U12263003 00000U12263002 00000A12174020 00000LA70A4A10 00000L3A5F3C9C 0000AL12233002 0000AL12233001 00000L020E0A85 0000AB12018004 00000Z13168003 00000Z13168002 0000AD12269003 0000AD12269002 00000LE4B6A1CA 00000L3AB2DE60 00000P11312012 0000AL12144002 000000G9337008 0000AM12208001 0000AP12123001 0000AQ11291001 00000T12333004 00000L3A73153D 00000P11312019 00000H13058001 0000AG12118006 00000X13036003 00000W13204008 0000AM12222004 0000AM12222003 00000A12219002 00000A12219001 00000R12086007 00000G13078002 00000G13078005 00000Z12251001 0000AP12123002 00000L02577B48 000000Z9350001 0000AE11294002 00000M13046005 00000LA712358B 00000W10202001 00000H10098001 00000A10194004 00000A10194003 00000A10194002 00000X13036001 00000T13044001 00000R13025001 00000Q13022007 00000P13088001 00000N13024002 00000L13171002 00000G13078003 0000AM12222002 00000LA70A48C3 0000AP12123004 0000AL12144004 00000L3A7315C1 0000AX12262003 0000AM12261001 00000S11020004 00000S11020001 00000N10337018 00000L3A5BF838 00000L3A79AB03 00000L3A5BF827 00000E10336003 00000L3A5BF84E 00000L3A75873B 00000L3A5BF911 00000L3A9CCE94 00000L3A77E646 00000N12146001 00000L8B19A930 0000AG12118002 0000AL12142001 00000X13036002 00000Y12317002 0000AD12202004 0000AC12353003 0000AC12353002 00000L3AB68E28 0000AJ12082001 0000AH12080001 0000AC12353001 00000L0257B583 00000M12048003 00000E12332006 000000L9343010 00000K13143003 00000K13143002 00000K13143001 00000N13024001 00000L10351001 00000H10085001 00000E12332010 0000AQ12290001 0000AN11298006 0000AD12125001 00000L3A5249E5 00000F12320001 00000X12244001 0000AE11234004 0000AD13072001 00000T13073003 00000T13073001 00000Q13074001 00000V10243002 00000V10243001 00000D10232001 00000Q13022006 00000N13064005 00000N13064001 00000N12348004 00000N10127004 00000J13063002 0000AB13113001 00000E12332007 00000L3AB68DBD 0000AC12130002 00000N12146006 00000N11159001 00000M13123005 00000M13123004 00000N10337013 00000N10337004 00000A12219006 00000A12219004 00000A12219003 00000L3AB1F8BA 00000L3A557466 0000AH12265006 00000LA704C005 0000AC13154006 00000Z13168001 00000L3A3C7D9D 00000W13115011 00000L3A9C8A55 00000L3A9C8A23 00000X11076002 00000X11076001 00000W13031001 00000Q11060001 00000N11028002 00000N11028001 00000M11069002 00000L3A70C8C6 00000N10337012 0000AL12142004 0000AL12142003 00000X12040003 00000X12040001 00000U10246001 00000N12348006 00000N12348005 00000L3A4F064F 00000L3A4F0555 00000AE9295001 0000AG12118005 0000AG12118004 0000AG12118003 00000P13151001 0000AD10244002 00000U10251002 00000F10229008 00000G10312004 00000G10312003 00000G10312001 00000W11054001 00000R11031001 00000M11069001 00000L3A2A1F16 00000L3A2A1F15 000000W9351001 00000L3AB68D9B 00000D12363002 00000D12363001 00000N11172003 00000N11172002 0000AL12233005 00000A12219009 00000A12219005 00000L022E5E3B 00000S11049002 00000R11052001 00000L3A2A2083 000000Z9309001 0000AL12142009 0000AE12041001 00000R11027005 00000R11027004 00000Q11070001 00000L3A4F066C 000000L9343001 00000W11054002 00000T11061003 00000T11061001 00000D11066001 00000332781GE4 Class II GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. GE Healthcare, LLC
Devices AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. 006 00000H11027003 00000H11027002 00000H11027001 00000E10336009 00000E10336007 00000E10336006 00000E10336005 0000ZA12156001 00000Y12172004 00000E12332016 00000E12332015 00000E12332014 00000E12332012 00000E12332011 00000E12332002 00000Z11074002 0000AK12313002 0000AK12313001 0000AB10126002 00000T10123004 00000T10123002 00000T10123001 00000H10028003 00000LE23E65BE 00000L3A3C7CDB 0000AS12310002 00000F10229002 00000F10229001 000000G9337012 0000AS12310001 00000X12255001 00000L3A6CE9F2 00000M10189003 00000M10189002 00000J10208004 00000J10208001 00000L3A2AE16C 00000L3A330990 0000AL12142002 0000AG12137002 0000AG12137001 00000Z11074001 00000V11073004 00000V11073003 00000S13183004 00000S13183003 00000S13183002 00000S11020005 00000R12115002 00000R12115001 00000N11111002 00000N11105004 00000L12114001 00000L11098001 00000J13127001 00000J11077005 00000B11131011 00000B11131005 000000G9337017 0000AC12277002 00000W11101003 00000R11031002 00000R11027001 00000ZA9324001 00000U10061001 00000T10071001 00000M10075002 00000M10075001 00000LA8CEAF88 000000G9337020 0000AB11266003 0000AB11266002 0000AB11266001 00000K11179002 00000K11179001 0000AD12125008 0000AD12125007 0000AD12125005 00000T11061002 000000L9343005 00000K11117001 00000H11147005 00000H11147004 00000H11147001 00000M12157001 00000L13134009 00000L13134007 00000L13134006 00000S11020002 00000R11020006 00000R11020004 00000R11020003 00000J11024005 00000J11024004 00000J11024003 00000J11024002 00000P11278001 00000K11259005 00000K11259004 00000C10256003 00000C10256002 00000C10256001 00000L3A6CEB46 00000S13183001 0000AB10126004 0000AB10126003 00000N10127003 00000M10225001 00000J10208002 00000A10194005 00000J10215003 00000J10215002 00000L3A2544FB 00000L02546F3B 00000Z13168004 00000LA715C6B3 00000X11362002 00000J12026001 00000J12025011 00000J12025010 00000J12025009 00000J12025003 00000J12025002 0000AV12283003 0000AQ12290002 0000AL12296003 0000AL12296002 0000AL12296001 0000AC12279002 00000N12033007 00000T11061004 00000M10146001 000000G9337013 000000G9337015 00000N10337010 00000N10337009 00000N10337008 00000Z12166004 00000N10337001 00000M12157005 00000J12025006 00000J12025005 00000J12025004 00000J12025001 000000L9343004 00000W13115012 00000W13115010 00000W13115009 00000W13115008 00000W13115006 00000W13115005 00000W13115004 00000W13115002 00000W13115001 00000K13120002 00000K13120001 00000J13079001 00000U10259002 00000U10258003 00000U10258002 00000L10286003 00000T12032009 00000T12032008 00000T12032007 00000T12032003 00000T12032002 00000T12032001 00000A12174010 00000A12174008 00000L3A51377D 000000G9337007 0000AX12262007 00000S11019008 00000S11019007 00000S11019005 00000S11019004 00000S11019003 00000N10337017 00000N10337016 00000N10337015 00000N10337006 00000N10337005 00000E10336002 00000E10336001 0000AM12222005 00000A12174004 00000L3A6CEAFD 00000L3A6CD7DE 00000L3A6CD7CC 00000L3A6CEB06 00000L0247DC13 00000L0246DCE9 000000G9337016 00000L3A25474B 0000AD12202003 0000AD12202002 0000AD12202001 00000LFB4CD024 0000AD12125002 000SX976365012 00000L020E0B44 00000L3AAFB1B5 00000J10215001 00000LA7072149 00000LA8CE7F5A 00000K12215002 00000K12215001 00000U12263004 0000AK12313003 00000H10131002 0000AB12018003 00000P11059001 00000K13008002 0000AE11234002 00000P11235001 00000B12305001 00000Q13094001 00000N13163004 0000AN11298007 000000G9337018 00000G10161001 00000278637GE4 00000L026876FF 000000Z9356001 00000T10109001 00000L10106001 00000H10028002 00000L143CFC99 00000P12335001 00000LA7047CBA 00000Y12317003 0000AL12144009 00000M11045001 000000Z9309003 00000Z12166001 00000S11049001 00000W10250001 00000L3A3C7DEF 0000AX12262006 0000AX12262002 0000AX12262001 00000N11159005 00000N11159004 00000U13158002 00000U13158001 000000M9322001 00000W13204003 00000W13204001 00000T13077004 00000T12338 Class II GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. GE Healthcare, LLC
Devices AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. 002 00000N10337007 0000AD10244001 00000F12030005 0000AC12279006 00000U11174003 0000AM12159001 00000U12104001 0000AC12130001 000000G9337009 00000A10194001 00000T11124001 00000N11125001 000000G9337010 0000AV12283001 0000AM12303005 0000AC12279005 00000U12263001 00000N11159003 00000E12332013 00000U10259001 00000T10294001 00000J10293001 00000R10105001 00000R12086006 0000AC13154005 00000R11166004 00000Q11152003 00000Q11152002 00000L11150001 00000H11147007 00000H11147003 00000H11147002 00000F11151001 00000J10113001 00000U11189001 00000E12332005 00000J13032003 00000J13032001 0000AH13150002 00000P13170001 00000S11020008 00000S11020007 00000S11020006 00000N11019001 00000P11312013 0000AC13154004 0000AE11234003 00000Q11048001 000000L9343008 00000G11175001 00000W12046002 00000W12046001 00000W11328008 00000T12334010 00000T12334009 00000S11081003 00000P11312010 00000W11328001 00000M11265004 00000H10028001 00000W13204009 00000W13204006 00000W13204005 00000W13204004 00000LA70D10E6 00000M10162002 00000G10161003 00000F10173001 00000Q11152001 00000N11330003 00000M11363001 00000Q11048002 000000L9343006 0000AX12262005 0000AX12262004 0000AE12041002 00000Q11060005 00000Q11060003 00000E10336010 00000E10336004 00000A10299005 00000A10299004 0000AQ11291002 0000AN11298002 000000G9337014 00000L3A5249C5 000000L9343002 00000W13028002 00000L10333003 00000L10333002 00000L10333001 00000H12059001 0000AN11298010 0000AN11298009 0000AL12142013 00000N10337011 0000AM12222007 0000AM12222006 00000J12025008 00000J12025007 0000AE12009001 00000P11312002 00000V11143003 00000V11143002 00000U10061002 00000P11146001 00000E10083003 00000E10083002 00000E10083001 00000Z11074003 00000N11028003 0000AF12285001 00000P11312008 00000B11131008 00000LA709D844 000000G9337005 0000AL12145002 0000AL12144007 0000AL12144001 000000L9343007 00000R11055001 00000P10008001 0000AH13150004 0000AH13150003 00000J10208003 00000X13036005 00000F10229004 00000F10229003 00000L0238B1D6 00000S11020009 0000ZA10285001 00000N10337003 00000N10337002 00000A10299001 00000P12242003 000000L9343003 00000M13046006 00000M13046001 00000Q13022009 00000Q13022005 00000Q13022001 0000AP12123006 0000AP12123005 0000AF11249001 00000R12086005 00000P13137003 00000P13137001 00000L13134005 00000F12320003 00000J11237001 0000AB12018002 00000P11312009 0000AC12130006 00000J13032002 000000G9337019 0000AL12145003 0000AL12144008 00000R11027003 00000F10229007 00000F10229006 00000A10299003 00000A10299002 00000T12179002 00000T12179001 000000G9337006 0000AD12038001 00000N12033004 00000N12033003 00000U10258001 00000U10251001 00000F10229005 0000AL12200001 0000AJ12174004 00000A12174013 00000P13105001 00000P13088002 00000F12320011 0000AB10126001 0000AG12165001 00000S13156003 00000D10232002 00000J11003001 000000W9351002 0000AJ12167001 0000AG12165004 0000AG12165003 00000Y12164002 00000M12157002 00000Q11060002 00000N12033002 00000G10312002 00000N12033006 00000R11020002 00000R11020001 00000P11073002 00000Y12340001 00000X11076003 00000E11084001 00000C11087001 0000AJ12174002 00000K12215003 00000A12174005 0000AJ12082005 0000AJ12082004 00000R12086001 00000V11073001 00000L3A9968B7 0000AA11075001 00000J11077002 0000AJ12174003 0000AF12207001 00000N13163003 00000N13163001 0000AH12265003 00000M12272002 00000Q11075001 00000W13031002 00000W13028001 00000U10042001 00000P13070001 00000L3A8FD142 00000S11019001 0000AL12144010 00000Q11173001 0000AB12083001 00000V10334003 00000V10334002 00000T10123003 00000P10159001 00000N13163006 00000N13163005 00000A12174015 00000W11328002 00000U11360001 0000AM12303004 0000AM12303001 00000M13046003 00000270626GE5 00000332780GE6 00000X13107001 00000Z12251005 00000LA70A45D3 0000AN11298001 00000N10337014 0000AH12286002 0000AH12286001 00000T12334001 0000AF11077001 0000AH12265005 00000T12032 Class II GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. GE Healthcare, LLC
Devices AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. 001 00000L10351002 00000C10363001 00000U11174002 00000U11174001 00000L10351003 00000S11287002 00000S11287001 00000V10245006 00000N11172001 00000S11222002 00000T12333001 00000S11222006 00000N13163002 00000L13122001 00000V10245001 00000T12334008 00000T12334005 00000X11354003 00000R13025002 00000P11146002 00000R10250001 00000M13123010 00000M13123009 00000M13123008 00000M13123007 00000S11222005 00000S11222003 0000AB10235006 00000N11028004 00000N11159008 00000N11159002 00000R11166005 00000R11166001 00000N11159006 00000H11147006 00000N12146004 00000N12146003 00000T13081001 0000AE11203001 00000R11027002 00000K13008003 00000K13008001 0000AB10235002 00000W11112005 00000R11166003 00000R11166002 0000AJ12167002 0000AG12165002 00000M13046004 00000S12349001 00000P13042002 00000L13171001 00000F12030004 00000F12030001 00000P11312011 00000P11312006 00000R13017001 00000K12097001 0000AF12258001 00000Z12251002 00000P12242005 0000AB10235003 00000N10260002 00000T12032010 00000Q12067001 00000V10245003 00000T10291002 00000N10260001 00000G10307001 00000L3A9C89CE 0000AL12144006 0000AL12144003 00000N12146012 00000N12146005 00000W10349002 00000M11265005 00000M11265003 00000X11354002 00000V11083001 0000AE11234001 0000AA11243003 00000R11202002 00000R11202001 00000Q11173004 00000Q11173003 00000G11175002 00000X13107002 00000W13115003 00000P13087002 00000G13078001 00000Z12158001 00000M12157004 00000M12157003 00000Z12166003 0000AC13154001 0000AA11243002 00000C12070001 0000AF13080001 00000G13078004 0000AC13154002 00000W11328005 00000W11328007 0000AD12125006 0000AC12130004 S082421120267A 0S082421120267 00000L3A4817AE 00000W10125001 00000R11042001 00000M11045002 00000L10351006 00000L13023001 00000N11105001 00000L3A620C24 00000W12346001 00000W11328006 00000W11328004 00000N12146002 0000AB12083003 00000Z12093002 00000Z12093001 00000R12086009 00000W13115007 00000P13170002 00000B11095001 00000P11312016 00000M13046002 00000Y11250001 00000Y12340002 00000T13077001 0000AM12303002 00000B12305002 00000W11328009 00000T12338001 00000P11312001 00000M13123001 00000T13073005 0000AC12254001 00000I13066001 00000H13039001 00000T12334003 00000R13018002 00000R10250002 00000V10245007 00000D10252002 00000X10350004 00000W10349001 00000L3A443C8F 00000L3A443C82 00000N12348003 00000N12348002 00000N12348001 00000V10245004 00000E10265003 00000E10265002 0000ZA10223001 00000E10265001 0000AG10264001 00000V10245008 00000L10277001 00000J13127002 0000AM11355001 00000X11354001 00000N11330002 00000B11131009 00000Y12317001 00000N13014002 00000L13134010 00000L13134002 00000W11054003 00000J13063001 00000LA713461D 00000M13123006 0000AD12269001 00000S12271001 00000N13014001 00000L13011001 00000X12244002 00000W11101002 00000W11101001 00000J11077003 00000P12242002 00000N12348007 00000U13043002 00000U13043001 00000P13042001 00000N11102001 00000B11131007 00000B11131002 0000AC13154003 0000AE12247001 0000AB10235005 00000T12334007 00000T12334006 00000T12334004 00000T12334002 00000M13065002 00000U13185001 00000S13156002 00000S13156001 00000Z12158002 00000N12146009 00000N12146008 00000L3A9C88B6 00000Q11173002 00000B11131006 0000AF13149001 00000Z12251003 00000X12255002 00000S11020003 00000J11024001 00000P13087001 00000N13093001 0000AM11355002 00000R11353001 00000L3AA5ADDB 0000AZ12227001 00000X12255003 00000Z12251004 000000G9337004 00000Y12172003 00000Y12172002 00000Y12172001 00000F12320005 00000F12320002 00000B11131001 0000AM12222001 0000AA12221002 0000AA12221001 00000F12320010 0000AM12303007 0000AM12303006 00000F12320009 00000F12320007 00000E10011005 00000E10011004 00000E10011002 00000E10011001 00000S12328003 00000S12328002 00000S12328001 00000F12320006 00000F12320004 0000AE11294001 00000T12032004 00000S11019010 00000S11019009 00000S11019002 00000R11020005 00000Q11060 Class II GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. GE Healthcare, LLC
Devices AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. Mfg Lot or Serial # 00000270627GE3 00000334603GE8 00000323252GE7 00000315108GE1 00000291160GE0 00000218194GE9 00000334300GE1 00000253041GE8 00000256043GE1 00000L3A331FA4 00000289595GE1 00000323665GE0 00000323664GE3 00000275711GE0 00000293133GE5 00000256042GE3 00000175340GE9 00000335983GE3 00000275712GE8 00000275709GE4 00000323672GE6 00000323671GE8 00000226324GE2 00000208598GE3 00000187433GE8 00000187429GE6 00000226323GE4 00000304907GE9 00000327610GE2 00000303033GE5 00000308064GE5 00000318457GE9 00000306536GE4 00000304924GE4 00000LA70CA012 00000187434GE6 00000321124GE0 00000321123GE2 00000222541GE5 00000284793GE7 00000298539GE8 00000171505GE1 00000304914GE5 00000304910GE3 00000303035GE0 00000303034GE3 00000229351GE2 00000315104GE0 00000327604GE5 00000337320GE6 00000280422GE7 00000L0372A1AE 00000275708GE6 00000270631GE5 00000260247GE2 00000224182GE6 00000207773GE3 00000334305GE0 00000334304GE3 00000334303GE5 00000332778GE0 00000330087GE8 00000293134GE3 00000224186GE7 00000300999GE0 00000304909GE5 00000304908GE7 00000321116GE6 00000323673GE4 00000287149GE9 00000287148GE1 00000L3A58A61D 00000172803GE9 00000311101GE0 00000301003GE0 00000L02408868 00000L3A868449 00000291164GE2 00000235878GE6 00000169498GE3 00000256046GE4 00000172679GE3 00000218121GE2 00000LB8CDAE78 00000L0235EBD6 00000222542GE3 00000172802GE1 00000311102GE8 00000226326GE7 00000226325GE9 00000330086GE0 00000332779GE8 00000266124GE7 00000L0235EBD7 00000175338GE3 00000235877GE8 00000L0270044E 00000334299GE5 00000334298GE7 00000334297GE9 00000323668GE4 00000323667GE6 00000323666GE8 00000306541GE4 00000306540GE6 00000306539GE8 00000306538GE0 00000306537GE2 00000334604GE6 00000298541GE4 00000298540GE6 00000308058GE7 00000308060GE3 00000308059GE5 00000298536GE4 00000171126GE6 00000L3A868442 00000241475GE3 00000171115GE9 00000332783GE0 00000321115GE8 00000320717GE2 00000320716GE4 00000320715GE6 00000320714GE9 00000298533GE1 00000296984GE8 00000296983GE0 00000296982GE2 00000296981GE4 00000171114GE2 00000222538GE1 00000268434GE8 00000256045GE6 00000300998GE2 00000300997GE4 00000300996GE6 00000298542GE2 00000251408GE1 00000247372GE6 00000247371GE8 00000247370GE0 00000171942GE6 00000339695GE9 00000339694GE2 00000339693GE4 00000339692GE6 00000332787GE1 00000332786GE3 00000332785GE5 00000332784GE8 00000327609GE4 00000327608GE6 00000287045GE9 00000287044GE2 00000323669GE2 00000278636GE6 00000260248GE0 00000229375GE1 00000229377GE7 00000229376GE9 00000171641GE4 00000171117GE5 00000171116GE7 00000315101GE6 00000312652GE1 00000312651GE3 00000312650GE5 00000312649GE7 00000294225GE8 00000294220GE9 00000294219GE1 00000294218GE3 00000293138GE4 00000262815GE4 00000175341GE7 00000L3A331E5D 00000328872GE7 00000L0235EF79 00000194706GE8 00000266125GE4 00000315105GE7 00000312648GE9 00000306542GE2 00000253042GE6 00000L3A254331 00000218195GE6 00000321117GE4 00000334596GE4 00000294222GE5 00000294221GE7 00000171118GE3 00000270630GE7 00000311099GE6 00000311098GE8 00000334308GE4 00000334307GE6 00000334306GE8 00000327601GE1 00000262813GE9 00000L026B2276 00000208599GE1 00000207770GE9 00000268435GE5 00000260246GE4 00000233075GE1 00000222537GE3 00000298537GE2 00000171128GE2 00000L021DFE1D 00000306828GE5 00000294223GE3 00000327603GE7 00000327602GE9 00000296980GE6 00000175339GE1 00000175337GE5 00000224183GE4 00000253648GE0 00000251409GE9 00000270629GE9 00000L3AA73A34 00000207771GE7 00000L3A331A81 00000330084GE5 00000308063GE7 00000308062GE9 00000180600GE9 00000208597GE5 00000L0219C8D1 00000171119GE1 00000340255GE9 00000337318GE0 00000241476GE1 00000235881GE0 00000T13077003 00000224184GE2 00000171506GE9 00000L3A3D0C02 00000172678GE5 00000235879GE4 00000L02167F58 00000260243GE1 00000218122GE0 00000334595GE6 00000334312GE6 00000334311GE8 00000L3A3D0C2D 00000171941 Class II GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. GE Healthcare, LLC
Devices AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. 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The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. GE Healthcare, LLC
Food Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled UPC - 90 count: 8 28054 00542 6 UPC- 180 count 8 28054 00149 7; Manufactured by: ProThera, Inc., Reno, NV 89521 Lot F3994 Class II ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol. ProThera, Inc.
Food Klaire Labs Vital-Zymes Chewable; Comprehensive Enzyme Supplement; 180 Chewable tablets. UPC 7 09616 0218 5 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521 Lot F3990 and C3516 Class II ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol. ProThera, Inc.
Food Klaire Labs Vital-Zymes complete; Comprehensive Enzyme Supplement; 120 Vegetarian tablets. UPC 790616310005 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521 Lot #'s 0613110, 0513156 and 0513157 Class II ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol. ProThera, Inc.
Food Klaire Labs Interfase; Enzyme Supplement; Packaged in 60 and 120 Vegetarian capsules bottles. UPC 60 ct.- 7 0961 012270 7; UPc 120 ct. - 7 09616-01229 1 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521 Lot #' 313127 Class II ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol. ProThera, Inc.
Food Klaire Labs Interfase Plus; Enzyme Supplement; 120 Vegetarian capsules bottles. UPC 7 09616 01228 4 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521 Notation: Product #6 Clean Cut Enzyme wasn't entered into RES because the product never left the warehouse. Lot #'s 0913039, 0913040, and 0413085 Class II ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol. ProThera, Inc.
Food GlutenFlam (K-52) Enzyme & Bioflavonoid Dietary Supplement, 60 vegetarian capsules Lot # 303025, 305038 Class II Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. Apex Energetics
Food SuperDigestZyme (Z22), Plant Enzyme and Cofactor Dietary Supplement, 100 tablets Lot# 303008, 304062, 306042. Class II Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. Apex Energetics
Food LGS-Zyme (Z12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, 120 Capsules Lot# 130444 Class II Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. Apex Energetics
Food RepairVite (K63), Enzyme-Based Herbal & Amino Acid Dietary Supplement Powder, Caramel Flavor, Net Wt. 0.34 lb (155g) Lot# 302048 304003 306007 Class II Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. Apex Energetics
Food All-Natural Greens Dietary Supplement; Manufactured Exclusively for NatureRich, Maple Grove, MN 55369. Lots: 3071520, 3071521, 3071522,03071523,3071524, 3071525, 3071526 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Food Natural Balanced Nutrition Vanilla Energy Shake Dietary Supplement; Manufactured for NatureRich, Maple Grove, MN. Lots: 3062615 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Food Vive Shake Up Your Health Chocolate; Made for and distributed by renewal wellness. Lots: 3090510, 3081910 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Food Empirical Labs Building Health SuperFuel Plus Mocha Flavor; Whey protein isolate (milk); Dietary Supplement Lots: 3061708 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Food Empirical Labs Building Health SuperFuel Tropical Dietary Supplement Lots: 3061708 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Food Dynamite Specialty Products Tri-Mins Daily Foundation, calcium, magnesium, potassium dietary supplement; 240 Capsules; Manufactured for Dynamite Marketing, Inc, Meridian, ID 83642. Lots: 3061705, 3072312 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Food Empirical Labs Building Health Superfuel; 240 Capsules Dietary Supplement Lots: 3072303 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Food Empirical Labs Building Health Inte-Zyme; 180 Capsules Dietary Supplement Lots: 3080109 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Food Empirical Labs Building Health Thyroid; 90 Capsules Dietary Supplement Lots: 3071708 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Food Empirical Labs Building Health Vascuzyme; 90 Capsules Dietary Supplement Lots: 3080104 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Food Empirical Labs Building Health P&L Enzymes; 180 Capsules Dietary Supplement Lots: 3080205 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Food Non-GMO Ingredients Go Green Fuel for the Entire Body Dietary Supplement. All-Natural Greens Dietary Supplement. Manufactured Exclusiveley for: Hsin Ten Enterprise USA, Inc. Industry, CA 91748. Lots: 3071520,3071521,3071522,3071523,3071524, 3071526 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Food Empirical Labs Building Health Digesti-Zyme; 180 Capsules Dietary SupplementSupplement Lots: 3080101 Class II Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. Empirical Laboratories, Incorporated
Devices Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems. All units of these IntelliSpace PACS. Class II Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. The missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation. Philips Healthcare Informatics, Inc.
Devices Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter. Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985. Class II St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended. St. Jude Medical
Food Beachbody Optimize Enzymes Capusles, 126 CT, 8 oz. Container size: JAR 8OZ WHITE 70MM NECK POLYPROPYLENE 126 capsules per bottle. Product labeling reads in part:" BEACHBODY ULTIMATE OPTIMIZE Promotes healthy metabolism and effective body funtions***DIETARY SUPPLEMENT 126 Capsules***BEACHBODY, LLC Santa Monica, CA***". Item# 5109-126 LOT#17952-1 Class II CGNP initiated this recall because the raw material Exclezyme received from Specialty Enzymes used by CGNP in the formulation of Beachbody Optimize Enzymes Capsules CG has been found to contain chloramphenicol. Cgnp Manufacturing
Food Beach Body Ultimate Reset Kit 2.0( each Kit consist of 1 bottle of the above optimize enzymes capsules product and 5 bottles of additional product) Product labeling reads in part:" BEACHBODY ULTIMATE RESET KIT 2.0*** BEACHBODY, LLC Santa Monica, CA***". Item# 5109-126 LOT#17952-1 Class II CGNP initiated this recall because the raw material Exclezyme received from Specialty Enzymes used by CGNP in the formulation of Beachbody Optimize Enzymes Capsules CG has been found to contain chloramphenicol. Cgnp Manufacturing
Food *** 1) Corn meal mix packaged in a paper bag labeled in part: Aunt Jemima; Buttermilk; Self-Rising White; Corn Meal Mix; Flour, Salt & Baking Powder Already Blended In; NET WT 32 OZ (2 LB); *** 2) Corn meal mix packaged in a paper bag labeled in part: Aunt Jemima; Buttermilk; Self-Rising White; Corn Meal Mix; Flour, Salt & Baking Powder Already Blended In; NET WT 5 LB *** 1) Aunt Jemima; Buttermilk Self-Rising White Corn Meal Mix NET WT 32 OZ (2 LB); UPC:  ...
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Class II Some Aunt Jemima brand Buttermilk Self-Rising Corn Meal Mix, Quick Grits Enriched with White Hominy, and Buttermilk Self-Rising Corn Meal Mix White have levels of aflatoxin above the legal limit.. Quaker Foods and Snacks North America
Food White grits packaged in a paper bag labeled in part: Smooth & Creamy; Aunt Jemima; Quick GRITS; Cooks in about 5 minutes; ENRICHED WHITE HOMINY; NET WT 36.8 oz. (2 lb. 4.8 oz.) 1043g Aunt Jemima Quick Grits Enriched White Hominy: UPC:30000 04260, 300000 42601; Best Before Date: February 26, 2014 Class II Some Aunt Jemima brand Buttermilk Self-Rising Corn Meal Mix, Quick Grits Enriched with White Hominy, and Buttermilk Self-Rising Corn Meal Mix White have levels of aflatoxin above the legal limit.. Quaker Foods and Snacks North America
Devices Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly into the hyperplastic tissue for the treatment of benign prostatic hyperplasia (BPH). The RF energy delivered by the system provides selective thermal ablation of prostate tissue to help reduce urethral constriction and relieve BPH voiding symptoms. The Prostiva RF Therapy System consists of the following major components: " Radio Frequency Generator " Hand Piece Kit " Telescope The Model 8929 Prostiva RF Therapy Hand Piece Kit contains the following single-use, disposable components: " One sterile Hand Piece with radio frequency cable (Model 8929) " One sterile Tubing System (Model 6101) " One non-sterile Return Electrode (Model 8934) The hand piece has two insulated electrode needles that deliver the radio frequency energy interstitially to the prostate. These needles are covered by insulating shields that localize the lesions within the prostate, protect the urethra from thermal damage, and eliminate collateral thermal damage. The Hand Piece stainless steel (SS) tube is inserted into the urethral canal up to the prostate with the aid of a telescope for visualization during the therapy. The Hand Piece features two insulated Nitinol needles inside the SS tube. The needles can be deployed (extended), at approximately a 90-degree angle from the SS tube, to a preset depth of between 12 mm and 22 mm (at 2 mm intervals). The needles inside the SS tube are deployed into, or retracted from the prostate, using the handle lever. RF energy is delivered through the needles to the prostate tissue. The RF energy creates molecular friction eventually resulting in tissue heating and cell death (therapy intent). Kit Lot Number: 215251, Hand Piece Lot Number: 13E005M. Class II Urologix is voluntarily recalling Prostiva RF Therapy Hand Piece Kits, Part Number 8929, Lot Number 215251 due to a Hand Piece not meeting an in-process force test specification. Urologix, Inc.
Devices Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0 Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4. Class II Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees. RAYSEARCH LABORATORIES AB
Devices DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye Lot Number 32794811 Class II One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product. DeRoyal Industries Inc
Devices Applied Medical's Inzii® 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch. Model Number CD004. Lot Nubmers: 1161268, 1161269, 1164934, 1168358, 1168361, 1169317, 1169318, 1170694, 1170700, 1170701, 1171214, 1172482, 1172664, 1174287, 1174793, 1174857, 1175123, 1175280, 1175472, 1176555, 1177023, 1177871, 1179069, 1179392, 1179460, 1179775, 1179890, 1180291, 1180411, 1180576, 1181647, 1181648, 1181649, 1181939, 1182760, 1182934, 1183225, 1183823, 1183957, 1184273, 1184728, 1184915, 1184916, 1187779, 1188817, 1189117,  ...
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Class II Applied Medical is conducting a voluntary recall of the Inzii® 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. The likelihood of this situation to occur and result in patient harm is highly unlikely; however, out of an abundance of caution for patient safety and a commitment to provide only the highest quality products, Applied has decided to recall all potentially affected units. Applied Medical Resources Corp
Devices Sarns" Soft-Flow® Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog Number 5762 Lot Numbers 0677300 Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow® Aortic Cannulae and Sarns" Venous Return Cannulae. Terumo Cardiovascular Systems Corporation
Devices Sarns" Soft-Flow® Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog Number 5798 Lot Numbers 0677301 Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow® Aortic Cannulae and Sarns" Venous Return Cannulae. Terumo Cardiovascular Systems Corporation
Devices Sarns" Soft-Flow® Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Catalog Number 5841 Lot Numbers 0677302 Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow® Aortic Cannulae and Sarns" Venous Return Cannulae. Terumo Cardiovascular Systems Corporation
Devices Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava. Catalog Number 9473 Lot Numbers 0689812 Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow® Aortic Cannulae and Sarns" Venous Return Cannulae. Terumo Cardiovascular Systems Corporation
Food Fruit Truffles - Cherry, Coconut, Key Lime, Lemon, Mango, Pear, Pineapple and Tangelo flavors. (6 piece count/4.5 oz) Pear, Lemon, Key Lime, Coconut flavors contain FD&C Y5 and/or Y6; (9 piece count/7 oz) Pear, Cherry, Tangelo, Coconut, Lemon, Key Lime flavors contain FD&C Y5 and/or Y6 ; (12 piece count/9 oz) Mango, Pineapple, Tangelo, Cherry, Pear, Coconut, Key Lime, Lemon flavors contain FD&C Y5 and/or Y6; Firm also sells 2 piece count/1.5 oz products. However, this product only contains 2 strawberry flavors and do not contain FD&C Y5 and/or Y6. Sold to the hospitality industry. Product of the USA. Manufactured by Torn Ranch, Petaluma, CA 94954 (6 piece count/4.5 oz) = ITEM CODE S307-H (9 piece count/7 oz) = ITEM CODE S308-H (12 piece count/9 oz) = ITEM CODE S309-H Lot numbers: 1453-2963 Best By Date: October 24, 2013-February 23, 2014 (Best by date is 4 months after manufacturing date of product) Class II FDA inspection at the firm found that Yellow # 5 and 6 used in decoration on top of fruit truffles was not declared in the ingredient statement. Torn Ranch Inc.
Devices Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology. Model Numbers: 1600870-001, 1700470-001, 1700471-001. Class II The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7. Nobel Biocare Usa Llc
Devices Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311. Class II Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol. GlaxoSmithKline, LLC.
Devices Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system. Lot numbers not utilized. Serial Numbers:A5B1192003 A5B1192004, A5B11Y2005, A5B11Z2007, A5C1212008, A5C1212009, A5C1222010, A5C1232011, A5C1252012, A5C1262013, A5C1282014, A5C1292015, A5C12X2016, A5C12Y2017, A5C12Z2018, A5D1312019, A5D1322020, A5D1362021, XIB-A5A1082001, XIB-A5B11Y2006, A5D1372022, A5B1182002. Class II Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee SPEEDER (MJAJ-182A), SAR values lower than the actual SAR values may be displayed on the operating monitor. Toshiba American Medical Systems Inc
Devices Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms. SERIAL NUMBER IN THE US: 3300-203410 SERIAL NUMBERS INTERNATIONAL: 3300-203361, 3300-203362, 3300-203363, 3300-203364, 3300-203386, 3300-203387, 3300-203388, 3300-203389, 3300-203390, 3300-203391, 3300-203392, 3300-203393, 3300-203394, 3300-203395, 3300-203396, 3300-203397, 3300-203398, 3300-203399, 3300-203400, 3300-203401, 3300-203402, 3300-203403, 3300-203404, 3300-203405, 3300-203406, 3300-203407, 3300-203408, 3300-203409, 3300-203410, 3300-203443, 3300-203444, 3300-203445, 3300-203446, 3300-203447, 3300-203448, 3300-203449, 3300-203450, 3300-203451, 3300-203452, 3300-203453, 3300-203454, 3300-203455,  ...
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Class II Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors. Spacelabs Healthcare, Llc
Food Bairn Biologics Candisol; Natural Enzymes to Support a Health Gastrointestinal Tract. Dietary Supplement; Ingredients: Vegetarian Cellulase, Vegetarian Hemicellulase, Vegetarian Xylanase, Vegetarian Beta-glucanase, microcrystalline Cellulose, L-Leucine, Vegetable Capsule. Packaged in 40 and 120 count amber glass bottles. Bairn Biologics, P.O. Box 95966 Las Vegas, NV 89183 all lots manufactured from 2009 forward; Expiry dates: March 2011 through May 2015. Class II Firm was notified by supplier of xylanase enzymes that they were contaminated with Chloramphenicol. Bairn Biologics
Food Walnut shaped soft Cookie packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20644D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 3/20/14 With Korean language labeling product code: 20644D Expiration date: 3/20/14 Class II "Wheat" flour was not declared on the label Cho & So, Inc. DBA Oh Bok Bakery
Food Doughnuts packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20645D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 1/29/14 With Korean language labeling product code: 20645D Expiration date: 1/29/14 Class II "Wheat" flour was not declared on the label Cho & So, Inc. DBA Oh Bok Bakery
Food Sweet Bread known as Bam Bbang (Chestnut Bread) packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20646D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 1/29/14 With Korean language labeling product code: 20646D Expiration date: 1/21/14 Class II "Wheat" flour was not declared on the label Cho & So, Inc. DBA Oh Bok Bakery
Food Digestive Enzymes, 60 Capsules/Bottle under the following brand names: 21st Century Digestive Enzymes, 60 Capsules/Bottle. HyVee Digestive Eymes, 60 Capsules/Bottle. UPC Codes: 21st Century: 7-40985-22556-1, HyVee: 0-75450-31144-0. Lot Codes: 21st Century : 7465500, 7465501, 7658200. HyVee : 7757400. Expriation: 03/2016. Class II This voluntary recall is initiated because raw material used may contain trace amounts of the antibiotic chloramphenicol. 21st Century Healthcare, Inc.
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