• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON SC2000 Ultrasound System;

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
ACUSON SC2000 Ultrasound System;
see related information
Date Posted January 24, 2014
Recall Status1 Open
Recall Number Z-0824-2014
Recall Event ID 67209
Premarket Notification
510(K) Number
K123622 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.
Code Information Model number 10433816; Serial numbers lower than 401100. Serial numbers: 400935 400686 400597 400833 400140 400753 400752 400771 401016 400166 400635 400582 400983 400532 400580 400592 400804 400733 400737 400652 401036 400643 400746 400349 400784 400919 400685 400777 400186 400499 400896 400809 400259 400282 400758 400762 400831 400723 400402 400633 401027 400111 400319 400515 400942 400793 400699 400849 400816 400216 400212 400713 400764 400730 400734 401021 400215 400735 400920 401052 400815 400766 401018 400729 400731 400213 400903 400254 400670 400560 401048 401056 400280 400722 400945 400405 400407 400546 400975 400904 400982 400980 400151 400961 400941 400325 400562 401073 400242 400415 400952 400732 400444 400149 400543 400661 400547 400726 400939 400510 401050 400243 400779 401072 400106 400147 400173 400302 400347 400348 400453 400553 400557 400558 400995 400996 400936 400341 400289 400987 401009 400575 400922 400702 400125 400199 400200 400611 400755 400808 400926 400950 400744 400150 400806 400427 400426 400428 400429 400495 400756 400624 400568 400911 400418 400566 400977 400551 400801 400157 400696 400727 400834 400207 400933 401079 400115 400416 400422 400599 400600 400500 400180 400307 400711 400608 400601 401068 400927 400424 401033 400127 400642 400637 400880 400205 400569 400690 400745 401004 401074 400802 400778 400614 400524 400523 400240 400591 401037 400901 400247 400263 400511 400514 400276 400703 400281 400469 401046 400627 401032 400819 401060 401058 400113 400241 400825 400653 400328 400910 400844 400869 401059 400598 401057 400677 400332 400824 400607 400842 401076 400419 400323 400329 400651 401053 401097 400785 400644 400602 400237 400432 400684 400413 400938 400625 400335 400976 400330 400525 400714 400333 401094 400838 400971 400609 400434 400845 400522 400068 400085 400906 400916 401091 400863 400706 400871 400286 400780 401051 400256 400937 400327 400482 400846 401045 400594 400724 400973 400497 400490 400219 401039 400966 401017 400300 400588 400798 401026 400279 400512 400579 400191 400284 400761 400182 400187 400590 400544 400738 400741 400339 400632 400494 400805 400721 400161 400537 400596 400719 400688 400211 400159 400160 400172 400181 400158 400248 400249 400250 400298 400301 400192 400170 400184 400531 400539 400639 400812 401082 401085 400252 401087 400718 400837 400841 400750 400751 400705 400754 400561 400747 400850 400542 400417 400574 400576 400917 400559 400571 400255 400839 400748 400870 400879 400655 400578 400585 401019 401024 400645 400345 400606 400406 400692 400521 400984 400725 400278 400769 400423 400563 400943 400701 400262 400178 400915 400565 400928 400934 400616 400420 400823 400274 400275 400414 400876 400165 400760 400116 400271 400266 400430 400214 400581 400403 400498 400253 400412 400765 400728 401042 400189 400969 400897 400924 400908 400584 400587 400840 401086 400646 400796 401084 400836 400619 401000 400946 400948 400957 400963 400401 400603 400277 400990 400218 400342 400476 400472 400889 400887 400230 400763 400792 400789 400787 400790 400791 400794 400797 400610 400618 400231 400742 400292 400130 401030 401012 401043 400295 400118 400322 400698 400572 400799 400623 400088 400102 400667 400668 401065 401081 401083 400872 400868 400873 401041 400168 400129 400163 400535 401061 400086 400782 400810 400811 400196 400222 400135 400586 400673 400960 400989 401001 400063 400261 400299 400913 400462 400467 400474 400902 400244 400269 400460 400461 400465 400828 400773 400788 401008 400084 400767 400636 400442 400486 400487 400310 400311 400743 400225 400649 400641 400770 400350 400291 400634 400900 400662 400687 400065 400238 400023 400126 400265 400988 400953 400964 400229 400930 401075 401031 400233 400070 400454 400530 400436 400477 400314 400122 400204 400316 400346 400438 400501 400516 400638 400666 401011 400717 400907 400217 400290 400425 400439 400441 400443 400447 400437 400451 400471 400324 400803 400821 401015 400851 400852 400449 401007 401010 401020 400258 400220 400221 401080 401088 400861 400740 400117 400458 400459 400455 400457 400715 400914 401044 400179 400312 400776 400820 400048 400093 400132 400143 400431 400665 400676 400678 400683 400669 400817 400152 400617 400485 400069 400700 400992 400694 400736 401023 401025 400090 400923 400951 400978 400066 400153 400548 400554 400555 400303 400304 401049 400120 400483 400083 400092 400177 400138 400446 400156 400991 400464 400473 400224 400195 400545 400492 400029 400223 400228 400246 400206 400577 400123 400137 400197 400234 400972 400317 400313 400452 400478 400621 400404 400496 400226 400885 400245 400884 400848 400874 400883 400175 400795 400757 400967 400974 401028 400650 400663 400664 400564 400067 400128 400142 400940 400954 400955 400962 400489 400843 400921 401040 400519 400470 400479 400493 400855 400857 400956 400965 400194 400293 400720 400958 400768 400775 400536 400800 400520 401090 401078 400318 400320 400860 400862 400875 400912 400925 400309 400450 400807 400716 400712 400671 400813 400674 401070 400959 401029 400171 400998 400999 400145 400877 400326 400091 400526 400527 400529 400463 400968 400672 400174 400595 400613 400783 400786 400022 400024 400081 400986 400481 400484 400108 400124 400288 400297 400679 400680 400538 400541 400626 401054 401055 401067 401071 400881 400888 400890 400892 400898 400886 400622 400440 400448 400589 400818 400835 400814 400050 400466 400154 400164 400239 400631 400660 400227 400139 400620 400583 400270 400847 400630 400162 401069 400308 400141 400235 400475 400878 400236 400629 400640 400570 400689 400691 400893 400513 400829 400203 400528 401089 400573 400994 400997 400970 400693 401003 401013 401014 400832 400759 400905 400100 400264 400456 400552 400985 400944 400336 400979 400675 400287 400550 400929 401063 400615 400830 400882 400931 401022 400856
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View, California 94043-4045
For Additional Information Contact Sheila Pickering
650-694-5398
Manufacturer Reason
for Recall
The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Siemens sent an Customer Safety Advisory Notification letter on December 22, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to:. If you observe looseness in the attachment of the user interface module to the column on the ultrasound system, immediately stop using your system and contact your Siemens service representative for repair. Your local Customer Service Engineer will contact you to make the necessary repairs on your system. You will be contacted to schedule an appointment. If you have any questions, please contact your local service support person for information regarding timelines and status. Until the necessary repairs have been completed on your system, please share this information with all personnel within your organization will need to be aware of thls issue. As always, patient safety issues are a high priority, and we thus alert customers of product concerns which may occur undervarlous conditions. To date, no patient injury has been reported. This problem was discovered as part of our ongoing quality process. ®® ®® We sincerely regret any inconvenience this condition may cause in your daily operations. For further questions please call (650) 694-5398.
Quantity in Commerce 843 active units
Distribution Worldwide Distribution - US (nationwide) and the countries of Albania, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Brunei, Canada, Columbia, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Israel, Italy, Japan, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, Norway, Oman, P.R. China, Philippines, Poland, Qatar, Rep of Yemen, Republic Korea, Romania, Russian Fed. San Marino, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E. United Kingdom and Venezuela.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA INC.
-
-