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U.S. Department of Health and Human Services

Class 2 Device Recall GE DatexOhmeda Engstrom Carestation

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  Class 2 Device Recall GE DatexOhmeda Engstrom Carestation see related information
Date Initiated by Firm April 23, 2008
Date Posted September 24, 2008
Recall Status1 Terminated 3 on May 16, 2012
Recall Number Z-1829-2008
Recall Event ID 48080
510(K)Number K062710  
Product Classification Continuous Ventilator - Product Code CBK
Product GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The module bay allows the integration of various patient monitoring modules with the ventilator.
Code Information Serial Number CBCL01134 CBCL01133 CBCL01128 CBCL01089 CBCL01087 CBCL01084 CBCL01075 CBCL01072 CBCL01070 CBCL01068 CBCL01067 CBCL01051 CBCL01050 CBCL01022 CBCL01021- CBCL01019 CBCL01018 CBCL01015 CBCL01012 CBCL01011 CBCL01010 CBCL01009 CBCL01008 CBCL01007 CBCL01000 CBCL00998 CBCL00997 CBCL00996 CBCL00995 CBCL00994 CBCL00993 CBCL00985 CBCL00984 CBCL00983 CBCL00978 CBCL00975 CBCL00974 CBCL00973 CBCL00972 CBCL00971 CBCL00968 CBCL00967 CBCL00966 CBCL00965 CBCL00964 CBCL00963 CBCL00962 CBCL00959 CBCL00958 CBCL00957 CBCL00956 CBCL00955 CBCL00954 CBCL00953 CBCL00952 CBCL00951 CBCL00950 CBCL00949 CBCL00948 CBCL00947 CBCL00946 CBCL00945 CBCL00944 CBCL00943 CBCL00942 CBCL00941 CBCL00940 CBCL00939 CBCL00938 CBCL00937 CBCL00936 CBCL00935 CBCL00934 CBCL00933 CBCL00932 CBCL00931 CBCL00930 CBCL00929 CBCL00928 CBCL00927 CBCL00926 CBCL00925 CBCL00924 CBCL00923 CBCL00922 CBCL00916 CBCL00915 CBCL00914 CBCL00913 CBCL00912 CBCL00911 CBCL00910 CBCL00909 CBCL00908 CBCL00907 CBCL00906 CBCL00905 CBCL00904 CBCL00903 CBCL00902 CBCL00901 CBCL00900 CBCL00899 CBCL00898 CBCL00897 CBCL00896 CBCL00895 CBCL00894 CBCL00893 CBCL00892 CBCL00891 CBCL00890 CBCL00889 CBCL00888 CBCL00887 CBCL00886 CBCL00885 CBCL00884 CBCL00883 CBCL00882 CBCL00881 CBCL00880 CBCL00879 CBCL00878 CBCL00877 CBCL00876 CBCL00875 CBCL00874 CBCL00873 CBCL00872 CBCL00871 CBCL00870 CBCL00869 CBCL00868 CBCL00867 CBCL00866 CBCL00865 CBCL00864 CBCL00863 CBCL00862 CBCL00861 CBCL00860 CBCL00859 CBCL00858 CBCL00857 CBCL00856 CBCL00855 CBCL00854 CBCL00853 CBCL00852 CBCL00851 CBCL00850 CBCL00849 CBCL00848 CBCL00847 CBCL00846 CBCL00845 CBCL00844 CBCL00843 CBCL00841 CBCL00840 CBCL00839 CBCL00837 CBCL00836 CBCL00835 CBCL00833 CBCL00832 CBCL00831 CBCL00830 CBCL00829 CBCL00828 CBCL00827 CBCL00826 CBCL00825 CBCL00824 CBCL00823 CBCL00821 CBCL00820 CBCL00818 CBCL00817 CBCL00816 CBCL00815 CBCL00814 CBCL00813 CBCL00812 CBCL00811 CBCL00810 CBCL00809 CBCL00808 CBCL00807 CBCL00806 CBCL00805 CBCL00804 CBCL00803 CBCL00802 CBCL00801 CBCL00800 CBCL00799 CBCL00798 CBCL00797 CBCL00796 CBCL00795 CBCL00794 CBCL00793 CBCL00792 CBCL00791 CBCL00790 CBCL00789 CBCL00788 CBCL00787 CBCL00786 CBCL00785 CBCL00784 CBCL00783 CBCL00782 CBCL00781 CBCL00780 CBCL00779 CBCL00778 CBCL00777 CBCL00776 CBCL00775 CBCL00774 CBCL00773 CBCL00772 CBCL00771 CBCL00770 CBCL00769 CBCL00768 CBCL00767 CBCL00766 CBCL00765 CBCL00764 CBCL00759 CBCL00758 CBCL00757 CBCL00756 CBCL00755 CBCL00754 CBCL00753 CBCL00752 CBCL00751 CBCL00750 CBCL00749 CBCL00748 CBCL00747 CBCL00746 CBCL00745 CBCL00744 CBCL00743 CBCL00742 CBCL00741 CBCL00740 CBCL00739 CBCL00738 CBCL00737 CBCL00736 CBCL00735 CBCL00734 CBCL00733 CBCL00732 CBCL00731 CBCL00730 CBCL00729 CBCL00728 CBCL00727 CBCL00726 CBCL00725 CBCL00724 CBCL00723 CBCL00722 CBCL00721 CBCL00720 CBCL00719 CBCL00718 CBCL00717 CBCL00716 CBCL00715 CBCL00714 CBCL00713 CBCL00712 CBCL00711 CBCL00710 CBCL00709 CBCL00708 CBCL00707 CBCL00706 CBCL00705 CBCL00704 CBCL00703 CBCL00702 CBCL00701 CBCL00700 CBCL00699 CBCL00698 CBCL00697 CBCL00696 CBCL00695 CBCL00694 CBCL00693 CBCL00692 CBCL00691 CBCL00690 CBCL00689 CBCL00688 CBCL00687 CBCL00684 CBCL00683 CBCL00682 CBCL00681 CBCL00680 CBCL00679 CBCL00678 CBCL00677 CBCL00676 CBCL00675 CBCL00674 CBCL00673 CBCL00672 CBCL00671 CBCL00670 CBCL00669 CBCL00668 CBCL00667 CBCL00666 CBCL00665 CBCL00664 CBCL00663 CBCL00662 CBCL00661 CBCL00660 CBCL00659 CBCL00658 CBCL00657 CBCL00656 CBCL00655 CBCL00654 CBCL00653 CBCL00652 CBCL00651 CBCL00650 CBCL00649 CBCL00648 CBCL00647 CBCL00646 CBCL00645 CBCL00644 CBCL00643 CBCL00642 CBCL00641 CBCL00640 CBCL00639 CBCL00638 CBCL00637 CBCL00636 CBCL00635 CBCL00634 CBCL00633 CBCL00632 CBCL00631* CBCL00630* CBCL00629* 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CL00121 CBCL00120 CBCL00119 CBCL00118 CBCL00117 CBCL00116 CBCL00115 CBCL00114 CBCL00113 CBCL00112 CBCL00111 CBCL00110 CBCL00108 CBCL00107 CBCL00106 CBCL00105 CBCL00104 CBCL00103 CBCL00102 CBCL00101 CBCL00100 CBCK00883 CBCK00882 CBCK00881 CBCK00880 CBCK00879 CBCK00878 CBCK00877 CBCK00876 CBCK00875 CBCK00874 CBCK00873 CBCK00872 CBCK00871 CBCK00870 CBCK00869 CBCK00868 CBCK00867 CBCK00866 CBCK00865 CBCK00864 CBCK00863 CBCK00862 CBCK00861 CBCK00860 CBCK00859 CBCK00858 CBCK00857 CBCK00856 CBCK00855 CBCK00854 CBCK00853 CBCK00852 CBCK00851 CBCK00850 CBCK00849 CBCK00848 CBCK00847 CBCK00846 CBCK00845 CBCK00844 CBCK00843 CBCK00842 CBCK00841 CBCK00840 CBCK00839 CBCK00838 CBCK00837 CBCK00836 CBCK00835 CBCK00834 CBCK00833 CBCK00832 CBCK00831 CBCK00830 CBCK00829 CBCK00828 CBCK00827 CBCK00826 CBCK00825 CBCK00824 CBCK00823 CBCK00822 CBCK00821 CBCK00820 CBCK00819 CBCK00818 CBCK00817 CBCK00816 CBCK00815 CBCK00814 CBCK00813 CBCK00812 CBCK00811 CBCK00810 CBCK00809 CBCK00808 CBCK00807 CBCK00806 CBCK00805 CBCK00803 CBCK00802 CBCK00801 CBCK00800 CBCK00799 CBCK00798 CBCK00797 CBCK00796 CBCK00795 CBCK00794 CBCK00793 CBCK00792 CBCK00791 CBCK00790 CBCK00789 CBCK00788 CBCK00787 CBCK00786 CBCK00785 CBCK00784 CBCK00783 CBCK00782 CBCK00781 CBCK00780 CBCK00779 CBCK00778 CBCK00777 CBCK00776 CBCK00775 CBCK00774 CBCK00773 CBCK00772 CBCK00771 CBCK00770 CBCK00769 CBCK00768 CBCK00767 CBCK00766 CBCK00765 CBCK00764 CBCK00763 CBCK00762 CBCK00761 CBCK00760 CBCK00759 CBCK00758 CBCK00757 CBCK00756 CBCK00755 CBCK00754 CBCK00753 CBCK00752 CBCK00751 CBCK00750 CBCK00749 CBCK00745 CBCK00744 CBCK00743 CBCK00742 CBCK00741 CBCK00740 CBCK00739 CBCK00738* CBCK00737 CBCK00736 CBCK00735 CBCK00734 CBCK00733 CBCK00732 CBCK00730 CBCK00729* CBCK00728 CBCK00727 CBCK00725 CBCK00724 CBCK00723 CBCK00722 CBCK00721 CBCK00720 CBCK00719 CBCK00718 CBCK00717 CBCK00716 CBCK00715 CBCK00714 CBCK00713 CBCK00712 CBCK00711 CBCK00710 CBCK00709 CBCK00708 CBCK00707 CBCK00706 CBCK00705 CBCK00704 CBCK00703 CBCK00702 CBCK00701 CBCK00700 CBCK00699 CBCK00698 CBCK00697 CBCK00696 CBCK00695 CBCK00694 CBCK00693 CBCK00692 CBCK00691 CBCK00690 CBCK00689 CBCK00688 CBCK00687 CBCK00686 CBCK00685 CBCK00684 CBCK00683 CBCK00682 CBCK00681 CBCK00680 CBCK00679 CBCK00678 CBCK00677 CBCK00676 CBCK00675 CBCK00674 CBCK00673 CBCK00672 CBCK00671 CBCK00670 CBCK00669 CBCK00668 CBCK00666 CBCK00665 CBCK00664 CBCK00663 CBCK00662 CBCK00661 CBCK00660 CBCK00659 CBCK00658 CBCK00657 CBCK00656 CBCK00655 CBCK00654 CBCK00653 CBCK00652 CBCK00651 CBCK00650 CBCK00649 CBCK00648 CBCK00647 CBCK00642 CBCK00626 CBCK00614 CBCK00613 CBCK00612 CBCK00611 CBCK00560 CBCK00559 CBCK00558 CBCK00557 CBCK00556 CBCK00555 CBCK00554 CBCK00552 CBCK00551 CBCK00550 CBCK00469 and CBCK00464 
Recalling Firm/
Manufacturer		 GE Healthcare
9900 Innovation Drive
Wauwatosa WI 53226
For Additional Information Contact
608-221-1551
Manufacturer Reason
for Recall		 There is a correction associated with Engstrom Carestation with an integrated Aerogen Professional Nebulizer System. There is an issue relating to the removal of the nebulizer cable from nebulizer connection port, which, when done while the nebulizer is active, may result in the discontinuance of mechanical ventilation. This issue affects all of the Engstr¿m Carestations shipped between 12/4/2006
FDA Determined
Cause 2		 Device Design
Action Consignees were sent a "GE Urgent Medical Device Correction" letter on 5/12/08 addressed to Health Care Administrator/Risk Manger, Chief of Intensive Care & Director of Clinical Engineering. The letter described the affected product and the problem and provided a short term recommendation and a long term solution which included installation of a revised board on all affected Engstrom Carestations. A GE Healthcare Field Service Engineer to contact the facility to schedule the update. If you have questions, contact Melissa Davis at GE Healthcare at 1-800-345-2700 extension 3439.
Quantity in Commerce 1130
Distribution WI, GA, SC, TX, RI, NY, NM, IN VIETNAM, VENEZULA, UNITED KINGDOM, TURKEY, KOREA, JAPAN, ITALY, INDIA, ICELAND, HONG KONG, GREECE, GERMANY, GEORGIA, FRANCE, TUNISIA, THAILAND, SWITZERLAND, SPAIN, SOUTH AFRICA, FINLAND, ESTONIA, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CANADA, BRAZIL, BELGIUM, BANGLADESH, BAHRAIN, SLOVENIA, SINGAPORE, SAUDI, RUSSIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, NETHERLAND,MOROCCO, MEXICO, MAYLASIA, LYBIA, LEBANON, KUWAIT, AUSTRIA, AUSTRALIA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = DATEX-OHMEDA, INC.
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