FDA · Medical device recall

GE Datex-Ohmeda Aisys… and 1 more product

June 23, 2009

Date posted by the FDA: June 23, 2009
Status: Terminated
Filed by: GE Healthcare
Reason: Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds. The failure only affects the electrical portion of the switch. If the clinician does not intervene, the patient could experience hypoventilation leading to h
Distribution pattern: Worldwide distribution: USA, Canada, Mexico, YEMEN, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TUrKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIA, QATAR, PORTUGAL, POLAND, PERU, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, MACEDONIA, LITHUANIA, LIBYA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLoMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA.

2 products in this recall

GE Datex-Ohmeda Aisys…

Product: GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine.
Quantity: 3082
Codes and lots: ANAM00499 ANAM00500 ANAM00501 ANAM00502 ANAM00503 ANAM00504 ANAM00505 ANAM00506 ANAM00507 ANAM00508 ANAM00509 ANAM00510 ANAM00511 ANAM00514 ANAM00515 ANAM00516 ANAM00517 ANAM00520 ANAM00521 ANAM00522 ANAM00523 ANAM00526 ANAM00527 ANAM00528 ANAM00529 ANAM00530 ANAM00531 ANAM00532 ANAM00533 ANAM00537 ANAM00539 ANAM00540 ANAM00541 ANAM00542 ANAM00545 ANAM00546 ANAM00547 ANAM00548 ANAM00549 ANAM00550 ANAM00551 ANAM00553 ANAM00554 ANAM00555 ANAM00556 ANAM00557 ANAM00558 ANAM00559 ANAM00568 ANAM00569 ANAM00570 ANAM00571 ANAM00572 ANAM00573 ANAM00574 ANAM00575 ANAM00576 ANAM00577 ANAM00578 ANAM00579 ANAM00580 ANAM00581 ANAM00582 ANAM00583 ANAM00584 ANAM00585 ANAM00586 ANAM00587 ANAM00588 ANAM00592 ANAM00593 ANAM00594 ANAM00595 ANAM00596 ANAM00597 ANAM00598 ANAM00599 ANAM00600 ANAM00601 ANAM00602 ANAM00603 ANAM00604 ANAM00605 ANAM00606 ANAM00607 ANAM00608 ANAM00609 ANAM00610 ANAM00612 ANAM00613 ANAM00614 ANAM00615 ANAM00616 ANAM00617 ANAM00618 ANAM00619 ANAM00620 ANAM00621 ANAM00622 ANAM00636 ANAM00639 ANAM00656 ANAM00658 ANAM00659 ANAM00660 ANAM00661 ANAM00662 ANAM00663 ANAM00664 ANAM00665 ANAM00666 ANAM00669 ANAM00670 ANAM00671 ANAM00672 ANAM00673 ANAM00674 ANAM00675 ANAM00719 ANAM00722 ANAM00723 ANAM00724 ANAM00725 ANAM00726 ANAM00727 ANAM00728 ANAM00753 ANAM00754 ANAM00755 ANAM00756 ANAM00757 ANAM00758 ANAM00759 ANAM00760 ANAM00761 ANAM00763 ANAM00764 ANAM00765 ANAM00766 ANAM00767 ANAM00768 ANAM00769 ANAM00770 ANAM00771 ANAM00772 ANAM00773 ANAM00774 ANAM00775 ANAM00789 ANAM00790 ANAM00518 ANAM00519 ANAM00524 ANAM00525 ANAM00543 ANAM00544 ANAM00552 ANAM00589 ANAM00652 ANAM00699 ANAM00752 ANAM00534 ANAM00637 ANAM00732 ANAM00733 ANAM00734 ANAM00735 ANAM00736 ANAM00737 ANAM00738 ANAM00739 ANAM00740 ANAM00741 ANAM00742 ANAM00743 ANAM00716 ANAM00632 ANAM00633 ANAM00634 ANAM00635 ANAM00785 ANAM00786 ANAM00787 ANAM00704 ANAM00705 ANAM00706 ANAM00707 ANAM00708 ANAM00709 ANAM00746 ANAM00747 ANAM00748 ANAM00749 ANAM00750 ANAM00751 ANAM00700 ANAM00701 ANAM00702 ANAM00647 ANAM00648 ANAM00649 ANAM00650 ANAM00744 ANAM00745 ANAM00560 ANAM00561 ANAM00562 ANAM00563 ANAM00564 ANAM00640 ANAM00641 ANAM00642 ANAM00643 ANAM00710 ANAM00713 ANAM00653 ANAM00654 ANAM00655 ANAM00677 ANAM00678 ANAM00626 ANAM00627 ANAM00711 ANAM00712 ANAM00638 ANAM00762 ANAM00628 ANAM00629 ANAM00630 ANAM00703 ANAM00720 ANAM00721 ANAM00631 ANAM00776 ANAM00512 ANAM00644 ANAM00645 ANAM00646 ANAM00782 ANAM00783 ANAM00784 ANAM00535 ANAM00536 ANAM00651 ANAM00717 ANAM00718 ANAM00538 ANAM00714 ANAM00715 ANAM00565 ANAM00566 ANAM00567 ANAM00590 ANAM00591 ANAM00729 ANAM00730 ANAM00731 ANAM00513 ANAM00623 ANAM00624 ANAM00625 ANAM00676 ANAM00679 ANAM00680 ANAM00681 ANAM00682 ANAM00683 ANAM00684 ANAM00685 ANAM00686 ANAM00687 ANAM00688 ANAM00689 ANAM00690 ANAM00691 ANAM00692 ANAM00693 ANAM00694 ANAM00695 ANAM00696 ANAM00697 ANAM00698 ANAM00777 ANAM00778 ANAM00779 ANAM00780 ANAM00781 ANAM00788 ANAM00611 ANAM00667 ANAM00668 ANAH00115 ANAH00116 ANAH00117 ANAH00124 ANAH00126 ANAJ00100 ANAJ00101 ANAJ00106 ANAJ00107…
Recall started: Feb. 5, 2009
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Component design/selection
What the company told customers: GE Healthcare contacted consignees via two "Urgent Medical device Correction" letters dated February 5, 2009 and March 10, 2009. The letters are addressed to 3 titles within the affected accounts; Healthcare Administrator/Risk Manger, Chief of Intensive Care and Director of Biomedical Engineering. The letters describes the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. The second letter dated March 10, 2009 includes 700 serial numbers that were missing from the first letter. The second letter was only mailed to the consignees of the additional 700 units.
Recall number: Z-1425-2009

GE Datex-Ohmeda Advance Anesthesia Gas-Machine

Product: GE Datex-Ohmeda Advance Anesthesia Gas-Machine.
Quantity: 6243
Codes and lots: ANBM00531 ANBM00532 ANBM00534 ANBM00535 ANBM00536 ANBM00537 ANBM00538 ANBM00539 ANBM00540 ANBM00541 ANBM00542 ANBM00543 ANBM00544 ANBM00545 ANBM00546 ANBM00547 ANBM00548 ANBM00549 ANBM00550 ANBM00551 ANBM00553 ANBM00554 ANBM00555 ANBM00556 ANBM00557 ANBM00558 ANBM00559 ANBM00560 ANBM00586 ANBM00587 ANBM00588 ANBM00589 ANBM00590 ANBM00591 ANBM00620 ANBM00622 ANBM00623 ANBM00624 ANBM00625 ANBM00626 ANBM00627 ANBM00628 ANBM00629 ANBM00630 ANBM00631 ANBM00632 ANBM00633 ANBM00634 ANBM00635 ANBM00636 ANBM00637 ANBM00638 ANBM00639 ANBM00640 ANBM00643 ANBM00644 ANBM00672 ANBM00673 ANBM00699 ANBM00705 ANBM00706 ANBM00707 ANBM00708 ANBM00709 ANBM00775 ANBM00776 ANBM00779 ANBM00798 ANBM00799 ANBM00800 ANBM00830 ANBM00831 ANBM00832 ANBM00833 ANBM00834 ANBM00835 ANBM00839 ANBM00842 ANBM00843 ANBM00844 ANBM00845 ANBM00846 ANBM00847 ANBM00848 ANBM00849 ANBM00850 ANBM00851 ANBM00881 ANBM00882 ANBM00883 ANBM00884 ANBM00885 ANBM00886 ANBM00887 ANBM00889 ANBM00890 ANBM00891 ANBM00892 ANBM00893 ANBM00895 ANBM00896 ANBM00897 ANBM00898 ANBM00899 ANBM00900 ANBM00901 ANBM00902 ANBM00903 ANBM00904 ANBM00905 ANBM00906 ANBM00907 ANBM00908 ANBM00909 ANBM00910 ANBM00911 ANBM00912 ANBM00913 ANBM00914 ANBM00915 ANBM00916 ANBM00917 ANBM00918 ANBM00920 ANBM00921 ANBM00922 ANBM00923 ANBM00924 ANBM00925 ANBM00927 ANBM00928 ANBM00929 ANBM00930 ANBM00931 ANBM00932 ANBM00933 ANBM00934 ANBM00935 ANBM00936 ANBM00937 ANBM00938 ANBM00939 ANBM00940 ANBM00941 ANBM00942 ANBM00943 ANBM00944 ANBM00945 ANBM00946 ANBM00947 ANBM00948 ANBM00949 ANBM00950 ANBM00951 ANBM00952 ANBM00953 ANBM00954 ANBM00955 ANBM00956 ANBM00957 ANBM00958 ANBM00968 ANBM00970 ANBM00971 ANBM00533 ANBM00617 ANBM00621 ANBM00926 ANBM00959 ANBM00960 ANBM00961 ANBM00962 ANBM00963 ANBM00964 ANBM00965 ANBM00966 ANBM00967 ANBM00694 ANBM00695 ANBM00697 ANBM00698 ANBM00701 ANBM00794 ANBM00795 ANBM00796 ANBM00797 ANBM00738 ANBM00739 ANBM00742 ANBM00743 ANBM00744 ANBM00747 ANBM00748 ANBM00749 ANBM00750 ANBM00751 ANBM00752 ANBM00753 ANBM00754 ANBM00755 ANBM00805 ANBM00806 ANBM00807 ANBM00826 ANBM00827 ANBM00828 ANBM00829 ANBM00641 ANBM00660 ANBM00857 ANBM00642 ANBM00659 ANBM00661 ANBM00735 ANBM00736 ANBM00737 ANBM00740 ANBM00770 ANBM00771 ANBM00772 ANBM00773 ANBM00774 ANBM00780 ANBM00781 ANBM00782 ANBM00783 ANBM00784 ANBM00785 ANBM00726 ANBM00727 ANBM00728 ANBM00813 ANBM00814 ANBM00592 ANBM00593 ANBM00594 ANBM00595 ANBM00596 ANBM00597 ANBM00598 ANBM00599 ANBM00600 ANBM00601 ANBM00602 ANBM00603 ANBM00604 ANBM00605 ANBM00606 ANBM00607 ANBM00608 ANBM00609 ANBM00610 ANBM00611 ANBM00648 ANBM00651 ANBM00756 ANBM00757 ANBM00758 ANBM00759 ANBM00760 ANBM00761 ANBM00762 ANBM00763 ANBM00764 ANBM00765 ANBM00767 ANBM00768 ANBM00769 ANBM00671 ANBM00714 ANBM00561 ANBM00584 ANBM00836 ANBM00837 ANBM00704 ANBM00645 ANBM00646 ANBM00647 ANBM00649 ANBM00650 ANBM00652 ANBM00654 ANBM00655 ANBM00665 ANBM00667 ANBM00696 ANBM00700 ANBM00702 ANBM00703 ANBM00741 ANBM00786 ANBM00787 ANBM00788 ANBM00789 ANBM00790 ANBM00804 ANBM00818 ANBM00571 ANBM00572 ANBM00573…
Recall started: Feb. 5, 2009
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Component design/selection
What the company told customers: GE Healthcare contacted consignees via two "Urgent Medical device Correction" letters dated February 5, 2009 and March 10, 2009. The letters are addressed to 3 titles within the affected accounts; Healthcare Administrator/Risk Manger, Chief of Intensive Care and Director of Biomedical Engineering. The letters describes the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. The second letter dated March 10, 2009 includes 700 serial numbers that were missing from the first letter. The second letter was only mailed to the consignees of the additional 700 units.
Recall number: Z-1426-2009

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1425-2009, Z-1426-2009. The agency record governs; check it and the company before acting.

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