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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72943

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 15, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Medical Systems, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.

Z-0677-2016
Recall number
Z-0677-2016
Initiated
December 15, 2015
Classification
Class II
Status
Terminated
Recalling firm
GE Medical Systems, LLC
Quantity
1081

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

Code information

AESPIRE 7900 ANCU00662 ANCU00813 ANCU00814 ANCU00815 ANCU00816 ANCU00817 ANCU00818 ANCU00597 ANCU00598 ANCU00599 ANCU00600 ANCU00601 ANCU00671 ANCU00672 ANCU00673 ANCU00676 ANCU00678 ANCU00683 ANCU00830 ANCU00832 ANCU00870 ANCU00871 ANCU00872 ANCU00873 ANCU00874 ANCU00875 ANCU00629 ANCU00630 ANCU00638 ANCU00639 ANCU00640 ANCU00641 ANCU00806 ANCU00604 ANCU00684 ANCU00836 ANCU00837 ANCU00839 ANCU00786 ANCU00680 ANCU00681 ANCU00625 ANCU00626 ANCU00677 ANCU00618 ANCU00619 ANCU00620 ANCU00602 ANCU00603 ANCU00448 ANCU00449 ANCU00770 ANCU00771 ANCU00865 ANCU00866 ANCU00867 ANCU00803 ANCU00605 ANCU00663 ANCU00682 ANCU00685 ANCU00458 ANCU00459 ANCU00831 ANCU00653 ANCU00820 ANCU00591 ANCU00592 ANCU00586 ANCU00583 ANCU00584 ANCU00585 ANCU00825 ANCU00593 ANCU00664 ANCU00838 ANCU00433 ANCU00679 ANCU00555 ANCU00456 ANCU00457 ANCU00590 ANCU00661 ANCU00669 ANCU00670 ANCU00674 ANCU00819 ANCU00807 ANCU00808 ANCU00809 ANCU00810 ANCU00811 ANCU00812 ANCU00588 ANCU00589 ANCU00455 ANCU00587 ANCU00868 ANCU00581 ANCU00582 ANCU00466 ANCU00467 ANCU00468 ANCU00469 ANCU00840 ANCU00434 ANCU00435 ANCU00436 ANCU00437 ANCU00438 ANCU00439 ANCU00440 ANCU00822 ANCU00823 ANCU00824 ANCU00827 ANCU00828 ANCU00654 ANCU00729 ANCU00730 ANCU00496 ANCU00675 ANCU00624 ANCU00826 ANCU00829 ANCU00465 ANCU00441 ANCU00844 ANCU00656 ANCU00876 ANCU00877 ANCU00878 ANCU00426 ANCU00427 ANCU00485 ANCU00470 ANCU00608 ANCU00609 ANCU00610 ANCU00611 ANCU00612 ANCU00613 ANCU00789 ANCU00617 ANCU00445 ANCU00446 ANCU00490 ANCU00491 ANCU00492 ANCU00493 ANCU00494 ANCU00495 ANCU00497 ANCU00498 ANCU00518 ANCU00519 ANCU00521 ANCU00522 ANCU00665 ANCU00666 ANCU00709 ANCU00710 ANCU00711 ANCU00772 ANCU00773 ANCU00845 ANCU00846 ANCU00687 ANCU00688 ANCU00737 ANCU00738 ANCU00859 ANCU00860 ANCU00861 ANCU00693 ANCU00694 ANCU00695 ANCU00851 ANCU00852 ANCU00853 ANCU00854 ANCU00855 ANCU00856 ANCU00857 ANCU00858 ANCU00500 ANCU00501 ANCU00505 ANCU00506 ANCU00507 ANCU00508 ANCU00509 ANCU00510 ANCU00511 ANCU00516 ANCU00517 ANCU00696 ANCU00697 ANCU00698 ANCU00699 ANCU00705 ANCU00706 ANCU00707 ANCU00708 ANCU00715 ANCU00712 ANCU00713 ANCU00714 ANCU00569 ANCU00570 ANCU00571 ANCU00572 ANCU00450 ANCU00512 ANCU00513 ANCU00514 ANCU00515 ANCU00648 ANCU00649 ANCU00650 ANCU00735 ANCU00736 ANCU00863 ANCU00442 ANCU00444 ANCU00781 ANCU00464 ANCU00499 ANCU00701 ANCU00523 ANCU00524 ANCU00525 ANCU00526 ANCU00527 ANCU00530 ANCU00531 ANCU00532 ANCU00533 ANCU00534 ANCU00535 ANCU00536 ANCU00537 ANCU00538 ANCU00539 ANCU00540 ANCU00541 ANCU00542 ANCU00543 ANCU00544 ANCU00545 ANCU00546 ANCU00547 ANCU00548 ANCU00549 ANCU00550 ANCU00551 ANCU00552 ANCU00553 ANCU00554 ANCU00594 ANCU00595 ANCU00596 ANCU00731 ANCU00732 ANCU00733 ANCU00739 ANCU00740 ANCU00741 ANCU00742 ANCU00743 ANCU00744 ANCU00745 ANCU00746 ANCU00747 ANCU00758 ANCU00759 ANCU00760 ANCU00761 ANCU00762 ANCU00763 ANCU00764 ANCU00765 ANCU00717 ANCU00718 ANCU00719 ANCU00720 ANCU00721 ANCU00722 ANCU00723 ANCU00724 ANCU00725 ANCU00726 ANCU00727 ANCU00728 ANCU00489 ANCU00528 ANCU00529 ANCU00716 ANCU00484 ANCU00700 ANCU00463 ANCU00606 ANCU00692 ANCU00864 ANCU00821 ANCU00504 ANCU00623 ANCU00502 ANCU00503 ANCU00785 ANCU00520 ANCU00556 ANCU00557 ANCU00558 ANCU00559 ANCU00560 ANCU00804 ANCU00805 ANCU00686 ANCU00488 ANCU00447 ANCU00647 ANCU00842 ANCU00454 ANCU00862 ANCU00451 ANCU00452 ANCU00453 ANCU00689 ANCU00690 ANCU00691 ANCU00425 ANCU00428 ANCU00429 ANCU00430 ANCU00431 ANCU00487 ANCU00561 ANCU00567 ANCU00568 ANCU00607 ANCU00615 ANCU00616 ANCU00621 ANCU00627 ANCU00642 ANCU00643 ANCU00645 ANCU00655 ANCU00657 ANCU00658 ANCU00659 ANCU00660 ANCU00667 ANCU00668 ANCU00782 ANCU00783 ANCU00784 ANCU00790 ANCU00791 ANCU00792 ANCU00797 ANCU00799 ANCU00802 ANCU00833 ANCU00834 ANCU00835 ANCU00841 ANCU00869 ANCU00879 ANCU00880 ANCU00881 ANCU00882 ANCU00883 ANCU00884 ANCU00646 ANCU00766 ANCU00767 ANCU00768 ANCU00769 ANCU00847 ANCU00848 ANCU00486 ANCU00432 ANCU00651 ANCU00652 ANCU00614 ANCU00843 ANCU00562 ANCU00563 ANCU00564 ANCU00565 ANCU00566 ANCU00573 ANCU00574 ANCU00575 ANCU00576 ANCU00577 ANCU00578 ANCU00579 ANCU00580 ANCU00622 ANCU00702 ANCU00703 ANCU00704 ANCU00787 ANCU00788 ANCU00793 ANCU00794 ANCU00795 ANCU00796 ANCU00798 AESPIRE VIEW APHU01097 APHU00884 APHU00885 APHU00886 APHU00887 APHU00888 APHU01044 APHU01045 APHU01046 APHU01047 APHU01048 APHU01049 APHU01109 APHU00641 APHU00560 APHU01035 APHU00923 APHU00924 APHU00969 APHU00970 APHU00971 APHU00895 APHU00972 APHU00742 APHU01133 APHU01134 APHU00737 APHU00738 APHU00739 APHU00740 APHU01180 APHU00554 APHU00555 APHU00500 APHU00731 APHU00732 APHU00733 APHU00734 APHU00735 APHU00736 APHU00777 APHU01087 APHU01126 APHU01127 APHU01128 APHU00493 APHU00881 APHU00882 APHU00995 APHU00553 APHU00559 APHU00528 APHU01031 APHU00516 APHU00580 APHU00581 APHU00582 APHU00583 APHU00610 APHU01132 APHU01146 APHU00597 APHU00598 APHU01129 APHU01130 APHU01101 APHU00889 APHU00741 APHU00729 APHU00730 APHU00796 APHU00797 APHU00706 APHU00716 APHU00717 APHU00718 APHU00719 APHU00720 APHU00721 APHU00722 APHU00723 APHU01099 APHU00491 APHU00495 APHU00700 APHU00701 APHU00702 APHU00703 APHU00704 APHU00705 APHU00767 APHU00798 APHU00800 APHU00806 APHU00807 APHU00808 APHU00809 APHU00810 APHU00811 APHU00812 APHU00813 APHU00814 APHU00815 APHU00816 APHU00817 APHU00890 APHU00517 APHU00518 APHU00519 APHU00520 APHU00820 APHU00821 APHU00859 APHU01094 APHU01095 APHU01096 APHU00556 APHU00492 APHU00463 APHU00464 APHU00465 APHU00466 APHU00467 APHU01118 APHU01119 APHU01120 APHU01121 APHU00490 APHU00496 APHU00758 APHU00759 APHU00760 APHU00761 APHU00762 APHU00763 APHU00764 APHU00765 APHU00766 APHU00489 APHU00757 APHU01125 APHU01175 APHU01176 APHU00602 APHU00603 APHU00839 APHU00991 APHU00992 APHU00521 APHU00514 APHU00501 APHU00966 APHU00967 APHU01023 APHU00914 APHU00917 APHU00557 APHU00918 APHU00922 APHU00529 APHU00530 APHU01064 APHU01065 APHU01077 APHU01100 APHU00645 APHU00646 APHU00647 APHU00915 APHU00916 APHU01147 APHU00851 APHU00903 APHU00904 APHU00905 APHU00906 APHU00907 APHU00573 APHU00574 APHU00575 APHU00576 APHU00577 APHU00578 APHU01110 APHU00842 APHU00843 APHU00844 APHU00845 APHU00846 APHU00847 APHU00689 APHU00690 APHU00691 APHU00935 APHU01152 APHU01148 APHU01149 APHU01150 APHU01151 APHU01153 APHU01154 APHU01155 APHU01158 APHU01160 APHU00932 APHU01159 APHU01156 APHU01157 APHU01192 APHU01195 APHU00552 APHU00751 APHU00752 APHU00801 APHU00802 APHU00803 APHU00531 APHU00532 APHU00533 APHU00534 APHU00535 APHU00536 APHU01188 APHU01189 APHU00596 APHU00612 APHU00613 APHU00614 APHU00615 APHU00616 APHU00617 APHU00618 APHU00619 APHU00620 APHU00678 APHU00679 APHU00959 APHU01003 APHU01005 APHU01006 APHU01197 APHU00649 APHU00920 APHU00938 APHU00939 APHU00726 APHU00609 APHU00650 APHU00651 APHU00652 APHU00931 APHU00947 APHU00948 APHU00949 APHU00950 APHU00957 APHU00958 APHU00999 APHU01001 APHU01002 APHU00960 APHU00728 APHU00484 APHU00487 APHU00590 APHU00591 APHU00579 APHU01000 APHU01032 APHU01033 APHU01034 APHU01209 APHU00599 APHU00515 APHU00653 APHU00654 APHU00822 APHU00961 APHU01024 APHU00611 APHU00522 APHU00523 APHU00936 APHU00937 APHU00946 APHU01004 APHU01090 APHU00819 APHU00633 APHU01009 APHU00823 APHU00824 APHU00825 APHU00826 APHU00827 APHU00828 APHU00829 APHU00830 APHU00831 APHU00832 APHU00871 APHU00872 APHU00873 APHU00874 APHU00875 APHU00876 APHU00877 APHU00648 APHU00745 APHU00746 APHU00747 APHU00748 APHU00749 APHU00750 APHU00524 APHU00525 APHU00795 APHU01036 APHU01037 APHU01038 APHU01039 APHU01040 APHU01041 APHU01042 APHU01043 APHU01083 APHU00933 APHU00934 APHU00635 APHU00592 APHU00593 APHU00594 APHU00622 APHU00623 APHU00624 APHU00625 APHU00627 APHU00628 APHU00629 APHU00630 APHU00639 APHU00506 APHU01056 APHU01057 APHU01058 APHU00595 APHU00621 APHU00626 APHU00631 APHU00634 APHU00636 APHU00637 APHU00638 APHU00470 APHU00471 APHU00472 APHU00474 APHU00475 APHU00640 APHU00709 APHU00710 APHU00711 APHU00655 APHU00455 APHU00456 APHU00457 APHU00458 APHU00459 APHU00460 APHU00461 APHU00462 APHU00504 APHU01102 APHU00779 APHU01141 APHU00908 APHU00778 APHU00963 APHU00964 APHU00965 APHU00600 APHU01107 APHU01108 APHU00744 APHU00940 APHU00941 APHU00942 APHU00943 APHU00944 APHU00953 APHU00954 APHU00955 APHU00956 APHU01181 APHU01182 APHU01183 APHU01184 APHU01185 APHU01186 APHU01187 APHU00694 APHU00695 APHU00696 APHU00697 APHU00698 APHU00699 APHU00537 APHU00538 APHU00539 APHU00540 APHU00541 APHU00542 APHU00543 APHU00544 APHU00545 APHU00546 APHU00547 APHU00548 APHU00549 APHU00550 APHU00551 APHU01190 APHU01081 APHU00743 APHU00604 APHU00605 APHU00606 APHU00607 APHU00608 APHU00677 APHU00712 APHU00713 APHU00714 APHU00768 APHU00769 APHU00770 APHU00771 APHU00727 APHU00753 APHU00754 APHU00755 APHU00756 APHU01135 APHU01136 APHU01137 APHU00818 APHU00670 APHU00503 APHU00962 APHU01078 APHU01079 APHU00502 APHU00668 APHU00891 APHU01179 APHU00512 APHU00588 APHU00589 APHU00666 APHU00772 APHU00780 APHU00788 APHU00789 APHU00790 APHU00854 APHU00855 APHU00856 APHU00857 APHU00858 APHU00870 APHU00912 APHU00913 APHU00919 APHU00925 APHU00926 APHU00927 APHU00928 APHU00929 APHU00930 APHU00968 APHU00973 APHU00974 APHU01059 APHU01060 APHU01061 APHU01062 APHU01063 APHU01074 APHU01075 APHU01131 APHU01139 APHU01140 APHU01142 APHU01144 APHU01145 APHU01173 APHU01177 APHU01178 APHU00508 APHU00509 APHU00510 APHU00511 APHU00863 APHU00864 APHU00865 APHU00866 APHU00867 APHU00868 APHU00869 APHU00693 APHU00835 APHU00836 APHU00837 APHU00838 APHU00898 APHU00899 APHU00900 APHU00901 APHU00902 APHU01020 APHU01021 APHU01022 APHU01072 APHU01073 APHU01088 APHU00505 APHU00680 APHU00681 APHU00852 APHU00853 APHU00996 APHU00682 APHU00683 APHU00684 APHU00997 APHU00897 APHU00998 APHU01098 APHU01143 APHU00656 APHU00657 APHU00658 APHU00659 APHU00660 APHU00661 APHU00707 APHU00708 APHU00883 APHU01091 APHU01092 APHU01093 APHU00840 APHU00841 APHU01084 APHU01085 APHU01086 APHU00773 APHU00774 APHU00775 APHU00776 APHU00892 APHU00893 APHU00894 APHU00685 APHU00686 APHU00834 APHU00804 APHU00805 APHU00791 APHU00792 APHU00497 APHU00498 APHU00499 APHU00672 APHU00673 APHU00674 APHU00675 APHU00676 APHU00513 APHU00558 APHU01080 APHU01174 APHU00669 APHU01082 APHU00601 APHU01089 APHU00692 APHU00632 APHU00793 APHU00794 APHU00921 APHU00850 APHU00860 APHU00861 APHU00862 APHU01010 APHU01011 APHU01012 APHU01013 APHU01014 APHU01015 APHU01016 APHU01017 APHU01018 APHU01019 APHU00848 APHU00849 APHU01138 APHU01168 APHU01169 APHU01170 APHU01171 APHU01172 APHU00945 APHU00724 APHU00725 APHU01026 APHU01027 APHU01028 APHU01052 APHU00687 APHU00688 APHU01122 APHU01123 APHU01124 APHU01161 APHU01162 APHU01163 APHU01164 APHU01165 APHU01166 APHU01167 APHU00878 APHU00879 APHU00880 APHU00951 APHU00952 APHU01103 APHU01104 APHU01105 APHU01106 APHU00671 APHU00833 APHU00662 APHU00663 APHU00664 APHU00665 APHU00667 APHU01025 APHU01029 APHU00526 APHU00527 APHU00642 APHU00643 APHU00644 APHU01066 APHU01067 APHU01030 APHU01068 APHU01069 APHU01070 APHU01071 APHU00896 APHU01050 APHU01051 APHU01076 APHU01053 APHU01054 APHU01055

Distribution pattern

Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.

device · product 2 of 6

GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures.

Z-0678-2016
Recall number
Z-0678-2016
Initiated
December 15, 2015
Classification
Class II
Status
Terminated
Recalling firm
GE Medical Systems, LLC
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

Code information

AMRU01022 AMRU01023

Distribution pattern

Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.

device · product 3 of 6

GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The Aestiva/5 MRI anesthesia system provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment.

Z-0679-2016
Recall number
Z-0679-2016
Initiated
December 15, 2015
Classification
Class II
Status
Terminated
Recalling firm
GE Medical Systems, LLC
Quantity
84

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

Code information

AMTU01048 AMTU01023 AMTU00163 AMTU01050 AMTU00172 AMTU00175 AMTU00176 AMTU01034 AMTU01047 AMTU01055 AMTU01001 AMTU01002 AMTU01021 AMTU01044 AMTU01042 AMTU01015 AMTU00178 AMTU00179 AMTU00162 AMTU01000 AMTU01012 AMTU01041 AMTU00167 AMTU01019 AMTU00177 AMTU01049 AMTU00171 AMTU00164 AMTU01066 AMTU01006 AMTU00168 AMTU01061 AMTU01060 AMTU01056 AMTU01057 AMTU01073 AMTU00154 AMTU00166 AMTU00174 AMTU01005 AMTU01035 AMTU00150 AMTU01024 AMTU01025 AMTU01026 AMTU01027 AMTU01037 AMTU00152 AMTU01040 AMTU01022 AMTU00157 AMTU00158 AMTU00159 AMTU00160 AMTU00170 AMTU01018 AMTU01009 AMTU01032 AMTU01046 AMTU01045 AMTU01020 AMTU01008 AMTU00165 AMTU01013 AMTU01014 AMTU01033 AMTU01016 AMTU01036 AMTU01038 AMTU00151 AMTU00169 AMTU01003 AMTU00161 AMTU01010 AMTU01064 AMTU01011 AMTU01004 AMTU01017 AMTU01031 AMTU01053 AMTU01058 AMTU01059 AMTU01039 AMTU01007

Distribution pattern

Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.

device · product 4 of 6

GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

Z-0680-2016
Recall number
Z-0680-2016
Initiated
December 15, 2015
Classification
Class II
Status
Terminated
Recalling firm
GE Medical Systems, LLC
Quantity
13

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

Code information

ANAU00153 ANAU00156 ANAU00152 ANAU00150 ANAU00151 ANAU00154 ANAU00155 ANAU00157 ANAU00158 ANAU00159 ANAU00160 ANAU00180 ANAU00181

Distribution pattern

Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.

device · product 5 of 6

GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

Z-0681-2016
Recall number
Z-0681-2016
Initiated
December 15, 2015
Classification
Class II
Status
Terminated
Recalling firm
GE Medical Systems, LLC
Quantity
2627

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

Code information

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APWU01529 APWU01413 APWU01414 APWU01415 APWU01153 APWU01154 APWU01915 APWU01916 APWU01917 APWU00830 APWU00831 APWU00832 APWU01950 APWU01951 APWU00972 APWU00974 APWU00977 APWU00978 APWU00979 APWU00981 APWU01835 APWU01836 APWU01837 APWU01842 APWU01843 APWU00912 APWU01377 APWU01786 APWU01635 APWU01636 APWU01918 APWU01919 APWU01920 APWU01921 APWU01000 APWU01001 APWU01002 APWU01003 APWU01004 APWU01005 APWU01006 APWU01007 APWU01008 APWU01009 APWU01010 APWU01011 APWU01012 APWU01013 APWU01014 APWU01015 APWU01016 APWU01017 APWU01018 APWU01019 APWU01020 APWU01021 APWU01642 APWU01643 APWU01644 APWU01645 APWU01646 APWU01647 APWU01648 APWU01649 APWU01371 APWU01373 APWU01374 APWU01375 APWU01376 APWU00722 APWU01435 APWU01436 APWU01437 APWU01438 APWU01439 APWU01440 APWU01441 APWU01442 APWU00825 APWU01135 APWU01136 APWU01137 APWU01138 APWU01139 APWU01140 APWU01141 APWU01142 APWU01807 APWU01808 APWU00915 APWU00925 APWU00926 APWU00826 APWU00898 APWU01952 APWU01953 APWU01954 APWU01955 APWU01956 APWU01957 APWU01958 APWU01400 APWU01401 APWU01402 APWU01792 APWU01793 APWU00789 APWU00806 APWU00807 APWU00808 APWU00809 APWU00810 APWU00811 APWU00812 APWU00813 APWU00814 APWU00815 APWU00816 APWU00817 APWU01378 APWU01379 APWU01380 APWU01381 APWU01382 APWU00836 APWU00989 APWU01110 APWU01111 APWU01112 APWU01745 APWU01746 APWU01747 APWU00884 APWU02030 APWU02031 APWU00914 APWU01679 APWU01419 APWU01799 APWU00799 APWU00800 APWU01805 APWU00872 APWU00873 APWU00874 APWU01592 APWU01779 APWU01780 APWU00822 APWU00823 APWU00824 APWU00783 APWU00784 APWU00785 APWU01117 APWU01118 APWU01119 APWU01120 APWU01121 APWU01122 APWU01887 APWU01888 APWU01889 APWU00886 APWU00887 APWU00888 APWU01904 APWU02039 APWU01290 APWU01291 APWU01787 APWU01981 APWU01982 APWU01983 APWU01984 APWU01985 APWU01986 APWU01987 APWU00827 APWU01851 APWU01852 APWU01853 APWU01854 APWU00936 APWU01761 APWU01762 APWU01763 APWU01764 APWU01765 APWU01766 APWU01767 APWU01768 APWU01769 APWU01770 APWU01771 APWU01772 APWU01773 APWU00891 APWU00892 APWU00933 APWU00934 APWU00935 APWU01220 APWU01221 APWU01222 APWU01223 APWU01224 APWU01225 APWU01226 APWU01227 APWU01228 APWU01229 APWU01230 APWU01231 APWU01232 APWU01233 APWU01234 APWU01235 APWU01236 APWU01237 APWU01238 APWU01239 APWU01255 APWU01256 APWU01257 APWU01258 APWU01259 APWU01260 APWU01261 APWU01262 APWU01263 APWU01264 APWU01268 APWU01269 APWU01270 APWU01271 APWU01272 APWU01273 APWU01274 APWU01275 APWU01276 APWU01277 APWU01278 APWU01279 APWU01280 APWU01281 APWU01282 APWU01283 APWU01284 APWU01285 APWU01286 APWU01287 APWU01288 APWU01289 APWU01206 APWU01207 APWU01208 APWU01209 APWU01210 APWU01211 APWU01212 APWU01213 APWU01214 APWU01215 APWU01216 APWU01217 APWU01218 APWU01219 APWU01458 APWU01459 APWU01460 APWU00931 APWU00932 APWU01818 APWU01819 APWU01820 APWU01821 APWU01822 APWU01823 APWU01824 APWU00908 APWU00909 APWU00910 APWU00911 APWU01928 APWU00930 APWU01855 APWU01856 APWU01857 APWU01858 APWU01859 APWU01860 APWU01861 APWU01862 APWU01863 APWU01864 APWU01865 APWU01866 APWU01867 APWU01868 APWU01869 APWU01870 APWU01871 APWU01872 APWU01873 APWU00939 APWU00940 APWU00941 APWU01029 APWU01030 APWU01031 APWU01032 APWU01033 APWU01034 APWU01035 APWU01036 APWU01037 APWU01038 APWU01039 APWU01040 APWU01041 APWU01042 APWU01043 APWU01044 APWU01045 APWU01046 APWU01047 APWU01048 APWU01049 APWU01050 APWU01051 APWU01661 APWU01662 APWU01663 APWU01664 APWU01874 APWU01875 APWU01461 APWU01462 APWU01463 APWU01596 APWU01597 APWU01512 APWU01850 APWU01387 APWU01388 APWU01389 APWU01390 APWU01391 APWU01392 APWU01393 APWU01394 APWU01395 APWU01396 APWU01397 APWU01511 APWU01060 APWU01534 APWU01730 APWU01731 APWU01778 APWU01678 APWU01523 APWU01749 APWU01750 APWU01729 APWU01881 APWU00848 APWU00849 APWU00850 APWU01776 APWU01892 APWU01893 APWU01894 APWU01895 APWU01896 APWU01533 APWU01148 APWU02037 APWU02038 APWU01485 APWU01429 APWU01430 APWU01967 APWU01968 APWU01969 APWU01970 APWU01971 APWU01972 APWU01973 APWU01974 APWU01975 APWU01976 APWU01977 APWU01978 APWU01979 APWU01423 APWU01403 APWU01151 APWU00921 APWU00922 APWU00923 APWU00969 APWU00970 APWU00971 APWU01883 APWU01884 APWU01876 APWU01877 APWU01878 APWU00828 APWU00829 APWU01022 APWU01023 APWU01024 APWU01025 APWU01589 APWU01590 APWU01591 APWU01804 APWU00796 APWU00924 APWU02035 APWU00893 APWU00894 APWU01738 APWU01739 APWU01740 APWU01741 APWU02060 APWU02062 APWU00801 APWU00802 APWU00803 APWU00804 APWU00805 APWU01696 APWU01697 APWU01593 APWU01594 APWU01084 APWU01085 APWU01086 APWU01432 APWU01433 APWU01431 APWU01091 APWU01092 APWU01677 APWU01947 APWU01948 APWU01959 APWU01960 APWU01961 APWU01962 APWU01963 APWU01964 APWU01965 APWU01966 APWU00781 APWU00782 APWU00787 APWU01603 APWU01604 APWU01605 APWU01606 APWU01607 APWU02046 APWU02047 APWU00838 APWU00839 APWU02021 APWU02022 APWU02023 APWU02024 APWU02025 APWU02026 APWU02027 APWU02028 APWU02029 APWU00794 APWU00821 APWU00875 APWU00876 APWU00877 APWU00878 APWU00879 APWU02040 APWU02041 APWU01800 APWU01806 APWU01116 APWU01660 APWU01742 APWU01743 APWU01744 APWU00818 APWU02063 APWU01152 APWU00916 APWU00917 APWU00918 APWU00919 APWU00920 APWU00927 APWU00928 APWU00929 APWU01134 APWU01416 APWU01711 APWU00790 APWU00771 APWU00772 APWU00773 APWU00774 APWU00775 APWU00797 APWU01890 APWU01891 APWU01372 APWU00986 APWU01814 APWU01815 APWU00982 APWU01166 APWU01167 APWU01398 APWU01399 APWU00987 APWU01845 APWU00903 APWU00904 APWU01292 APWU01777 APWU02059 APWU01598 APWU00820 APWU01052 APWU01424 APWU00776 APWU00777 APWU00778 APWU00779 APWU00780 APWU01123 APWU01124 APWU01125 APWU01126 APWU01127 APWU01128 APWU01339 APWU01698 APWU00984 APWU01583 APWU02071 APWU00719 APWU01830 APWU01880 APWU01531 APWU01532 APWU00720 APWU00721 APWU01831 APWU02032 APWU01053 APWU01784 APWU01879 APWU01945 APWU01944 APWU01464 APWU01465 APWU01466 APWU02049 APWU02050 APWU01404 APWU01405 APWU01406 APWU01801 APWU01802 APWU01803 APWU01026 APWU01732 APWU01386 APWU01946 APWU01832 APWU02048 APWU00706 APWU00890 APWU01833 APWU01846 APWU01847 APWU01848 APWU01849 APWU01407 APWU01408 APWU01409 APWU01656 APWU01657 APWU01658 APWU01659 APWU02033 APWU02034 APWU01113 APWU01524 APWU01530 APWU00786 APWU02036 APWU00880 APWU00792 APWU00793 APWU01427 APWU01428 APWU00851 APWU00852 APWU00853 APWU00854 APWU00855 APWU00856 APWU00857 APWU00858 APWU00859 APWU00860 APWU00861 APWU00862 APWU00863 APWU01712 APWU01713 APWU01714 APWU01715 APWU01716 APWU01717 APWU01718 APWU01719 APWU01720 APWU01721 APWU01722 APWU01723 APWU01724 APWU01725 APWU01726 APWU01727 APWU01728 APWU01751 APWU01752 APWU01753 APWU01754 APWU01755 APWU01756 APWU01757 APWU01758 APWU01759 APWU01760 APWU01908 APWU00905 APWU00906 APWU00907 APWU00983 APWU00988 APWU01385 APWU00833 APWU00834 APWU00835 APWU01434 APWU00788 APWU01417 APWU01748 APWU01882 APWU01980 APWU02042 APWU02043 APWU02044 APWU01695 APWU00770 APWU00791 APWU01733 APWU01734 APWU01735 APWU01513 APWU01514 APWU02086 APWU02087 APWU02089 APWU02091 APWU00795 APWU00881 APWU00882 APWU00883 APWU00895 APWU00896 APWU00897 APWU00899 APWU00900 APWU00901 APWU00902 APWU00942 APWU00943 APWU00944 APWU00945 APWU00946 APWU00947 APWU00948 APWU00949 APWU00950 APWU00951 APWU00952 APWU00953 APWU00954 APWU00955 APWU00956 APWU00957 APWU00958 APWU00959 APWU00960 APWU00961 APWU00962 APWU00963 APWU00964 APWU00965 APWU00966 APWU00967 APWU00968 APWU01027 APWU01028 APWU01061 APWU01062 APWU01063 APWU01064 APWU01065 APWU01066 APWU01067 APWU01068 APWU01069 APWU01070 APWU01071 APWU01072 APWU01073 APWU01074 APWU01075 APWU01076 APWU01077 APWU01078 APWU01079 APWU01080 APWU01081 APWU01082 APWU01145 APWU01146 APWU01147 APWU01420 APWU01425 APWU01483 APWU01484 APWU01515 APWU01516 APWU01517 APWU01518 APWU01519 APWU01816 APWU01817 APWU01834 APWU02016 APWU02045 APWU01637 APWU01143 APWU01144 APWU01588 APWU02069 APWU01467 APWU01468 APWU01469 APWU01470 APWU01471 APWU01472 APWU01473 APWU01474 APWU01475 APWU01476 APWU01477 APWU01478 APWU01479 APWU01480 APWU01481 APWU01482 APWU00819 APWU01506 APWU01507 APWU00885 APWU00798 APWU00837 APWU01087 APWU01164 APWU01165 APWU01250 APWU01251 APWU01252 APWU01253 APWU01525 APWU01526 APWU01527 APWU01528 APWU01536 APWU01537 APWU01538 APWU01539 APWU01584 APWU01585 APWU01586 APWU01587 APWU01535 APWU01093 APWU01094 APWU01905 APWU01906 APWU01907 APWU01293 APWU01294 APWU01295 APWU01129 APWU01130 APWU01115 APWU01809 APWU01810 APWU01811 APWU01812 APWU01813 APWU01650 APWU01651 AVANCE ANBU00119 ANBU00124 ANBU00134 ANBU00138 ANBU00139 ANBU00163 ANBU00121 ANBU00122 ANBU00123 ANBU00125 ANBU00126 ANBU00127 ANBU00128 ANBU00129 ANBU00130 ANBU00131 ANBU00120 AVANCE CS2 APKU01696 APKU01697 APKU01698 APKU01699 APKU01872 APKU01237 APKU01238 APKU01239 APKU01240 APKU01241 APKU01242 APKU01243 APKU01569 APKU01570 APKU02074 APKU01701 APKU01427 APKU01694 APKU01053 APKU02163 APKU02164 APKU01200 APKU01201 APKU01202 APKU01203 APKU01204 APKU01686 APKU01687 APKU01688 APKU01904 APKU01810 APKU01447 APKU01742 APKU01743 APKU01656 APKU01657 APKU01658 APKU01682 APKU01683 APKU01684 APKU01685 APKU01729 APKU01730 APKU01731 APKU01454 APKU01455 APKU01456 APKU01457 APKU01458 APKU01459 APKU01460 APKU01461 APKU01462 APKU01463 APKU01464 APKU01465 APKU01466 APKU01467 APKU01468 APKU01469 APKU01470 APKU01473 APKU01378 APKU01379 APKU01380 APKU01381 APKU01382 APKU01383 APKU01384 APKU01385 APKU01021 APKU02049 APKU02050 APKU02051 APKU02052 APKU02053 APKU02054 APKU02055 APKU02056 APKU02057 APKU02058 APKU02059 APKU02060 APKU02061 APKU02062 APKU02063 APKU02064 APKU02065 APKU02066 APKU02067 APKU02068 APKU02069 APKU02070 APKU02071 APKU02072 APKU02073 APKU02075 APKU02076 APKU02077 APKU02078 APKU02079 APKU02080 APKU02081 APKU02082 APKU02083 APKU02084 APKU02085 APKU02086 APKU02087 APKU02088 APKU02089 APKU02090 APKU02091 APKU02092 APKU02093 APKU02094 APKU02095 APKU02096 APKU02097 APKU02098 APKU02099 APKU02234 APKU02235 APKU02236 APKU02237 APKU02238 APKU02239 APKU02240 APKU02241 APKU02242 APKU02243 APKU02268 APKU02269 APKU02270 APKU02271 APKU02272 APKU02273 APKU02274 APKU02275 APKU02276 APKU02277 APKU02295 APKU02296 APKU02297 APKU02298 APKU02299 APKU02300 APKU02301 APKU02302 APKU02303 APKU02304 APKU02307 APKU02308 APKU02309 APKU02310 APKU02311 APKU02312 APKU02313 APKU02314 APKU02315 APKU02316 APKU02366 APKU02367 APKU01178 APKU01268 APKU01269 APKU01270 APKU01617 APKU01618 APKU01619 APKU01326 APKU01780 APKU01164 APKU01183 APKU01361 APKU01362 APKU01363 APKU01719 APKU01720 APKU01721 APKU01722 APKU01723 APKU02267 APKU00988 APKU02036 APKU02037 APKU02038 APKU01959 APKU01960 APKU01784 APKU01785 APKU01924 APKU01925 APKU01124 APKU02244 APKU02245 APKU02246 APKU02247 APKU02248 APKU02249 APKU02250 APKU02251 APKU02118 APKU02119 APKU02120 APKU02121 APKU02122 APKU01961 APKU01167 APKU01168 APKU01169 APKU01170 APKU01171 APKU01172 APKU01180 APKU01181 APKU01182 APKU01364 APKU02103 APKU02104 APKU01224 APKU01444 APKU01744 APKU01174 APKU01365 APKU01366 APKU01367 APKU01368 APKU01369 APKU01370 APKU01430 APKU01431 APKU01432 APKU01153 APKU02126 APKU02223 APKU02224 APKU02225 APKU02226 APKU01681 APKU01689 APKU01690 APKU01691 APKU01692 APKU01693 APKU02128 APKU02129 APKU01438 APKU02100 APKU02101 APKU02102 APKU02116 APKU02117 APKU02112 APKU02230 APKU01160 APKU01396 APKU01108 APKU01048 APKU01049 APKU01050 APKU01404 APKU01405 APKU01878 APKU02016 APKU02017 APKU02018 APKU01391 APKU01754 APKU01755 APKU01756 APKU01757 APKU01704 APKU01705 APKU01706 APKU01707 APKU01708 APKU02130 APKU02131 APKU02132 APKU02133 APKU02134 APKU02135 APKU02136 APKU02137 APKU02138 APKU02139 APKU02140 APKU02141 APKU02142 APKU02143 APKU02144 APKU02145 APKU02146 APKU02147 APKU02221 APKU02222 APKU02260 APKU02261 APKU02262 APKU02263 APKU02264 APKU02265 APKU02031 APKU02032 APKU01550 APKU02215 APKU02216 APKU02217 APKU02218 APKU02219 APKU02220 APKU02305 APKU02306 APKU01342 APKU01343 APKU01344 APKU01345 APKU01346 APKU01347 APKU01348 APKU01349 APKU01350 APKU01351 APKU01352 APKU01353 APKU01354 APKU01355 APKU01356 APKU01357 APKU01358 APKU02041 APKU02042 APKU02043 APKU01324 APKU01909 APKU01910 APKU01911 APKU01912 APKU01913 APKU01914 APKU01915 APKU01916 APKU01917 APKU01918 APKU01919 APKU02109 APKU02110 APKU02111 APKU01265 APKU01266 APKU02291 APKU02292 APKU01069 APKU01070 APKU01071 APKU01072 APKU01584 APKU01051 APKU01772 APKU01773 APKU01774 APKU01775 APKU01745 APKU01746 APKU01747 APKU01983 APKU01984 APKU01985 APKU01424 APKU01425 APKU01426 APKU02331 APKU02336 APKU02357 APKU02360 APKU02361 APKU01951 APKU01952 APKU01953 APKU01954 APKU01955 APKU01019 APKU01195 APKU01647 APKU01648 APKU01649 APKU02169 APKU02170 APKU02171 APKU02172 APKU02173 APKU02174 APKU02175 APKU02176 APKU02177 APKU02178 APKU02179 APKU02180 APKU02181 APKU02182 APKU01998 APKU01997 APKU01398 APKU01399 APKU01400 APKU01371 APKU01372 APKU01373 APKU01374 APKU01375 APKU01376 APKU01377 APKU01975 APKU01976 APKU01968 APKU01969 APKU01970 APKU01971 APKU01972 APKU01973 APKU01974 APKU01977 APKU01978 APKU01979 APKU01980 APKU01981 APKU01982 APKU01401 APKU01402 APKU01551 APKU01552 APKU01711 APKU01712 APKU01713 APKU02021 APKU02022 APKU02023 APKU01962 APKU01963 APKU01964 APKU01965 APKU01966 APKU01841 APKU01842 APKU01359 APKU02048 APKU01718 APKU01849 APKU01850 APKU01851 APKU01852 APKU01853 APKU01854 APKU01855 APKU01856 APKU01857 APKU01858 APKU01859 APKU02157 APKU02158 APKU02159 APKU02160 APKU02161 APKU02162 APKU01967 APKU02105 APKU01926 APKU02024 APKU02025 APKU02026 APKU02027 APKU02028 APKU01740 APKU01613 APKU01614 APKU01615 APKU01948 APKU01929 APKU01930 APKU01931 APKU01406 APKU01407 APKU01408 APKU01409 APKU01410 APKU01411 APKU01412 APKU01413 APKU01414 APKU01415 APKU01416 APKU01417 APKU01418 APKU01419 APKU01026 APKU01027 APKU02002 APKU01620 APKU01621 APKU01165 APKU02029 APKU02030 APKU02106 APKU01587 APKU01588 APKU01589 APKU01579 APKU01580 APKU01581 APKU01582 APKU00993 APKU01726 APKU01717 APKU01820 APKU01811 APKU01812 APKU01813 APKU01814 APKU01634 APKU01635 APKU01636 APKU01637 APKU01638 APKU01639 APKU01640 APKU01641 APKU01079 APKU01943 APKU01136 APKU01765 APKU01766 APKU01433 APKU01434 APKU01435 APKU01436 APKU01137 APKU01138 APKU01139 APKU01140 APKU01141 APKU01142 APKU01905 APKU01906 APKU02228 APKU02341 APKU02342 APKU02343 APKU02346 APKU01830 APKU01831 APKU01832 APKU01833 APKU01834 APKU01835 APKU01986 APKU01987 APKU01988 APKU01325 APKU00983 APKU00984 APKU02229 APKU01724 APKU01725 APKU02378 APKU02019 APKU02020 APKU01583 APKU01152 APKU01502 APKU01503 APKU01504 APKU01505 APKU01506 APKU01507 APKU01508 APKU01509 APKU01510 APKU01511 APKU01512 APKU01513 APKU01514 APKU01515 APKU01516 APKU01517 APKU01518 APKU01519 APKU01520 APKU01521 APKU01437 APKU01471 APKU01472 APKU01568 APKU01727 APKU01163 APKU01360 APKU01395 APKU01080 APKU01081 APKU01082 APKU01083 APKU01084 APKU01732 APKU01733 APKU01734 APKU01735 APKU01736 APKU01737 APKU01738 APKU01776 APKU01777 APKU01778 APKU01779 APKU02044 APKU02045 APKU02046 APKU02047 APKU01932 APKU01933 APKU01934 APKU01935 APKU01936 APKU01937 APKU01938 APKU01527 APKU01528 APKU01529 APKU01530 APKU01531 APKU01532 APKU01533 APKU01534 APKU01535 APKU01536 APKU01537 APKU01538 APKU01539 APKU01540 APKU01541 APKU01542 APKU01543 APKU01544 APKU01545 APKU01546 APKU01547 APKU01548 APKU01403 APKU01062 APKU01063 APKU01064 APKU01065 APKU01066 APKU01067 APKU01068 APKU01327 APKU01328 APKU01329 APKU01330 APKU01331 APKU01332 APKU01333 APKU01334 APKU01335 APKU01336 APKU01386 APKU01387 APKU01388 APKU01389 APKU01390 APKU01392 APKU01393 APKU01394 APKU01158 APKU01159 APKU01397 APKU00977 APKU00978 APKU00979 APKU00980 APKU00981 APKU00982 APKU00985 APKU00986 APKU00987 APKU00989 APKU00990 APKU00991 APKU00992 APKU02039 APKU02040 APKU01090 APKU01091 APKU01092 APKU01093 APKU01094 APKU01095 APKU01096 APKU01097 APKU01098 APKU01099 APKU01100 APKU01101 APKU01210 APKU01218 APKU01646 APKU01112 APKU01113 APKU02167 APKU02168 APKU01023 APKU01024 APKU01025 APKU02227 APKU01817 APKU01029 APKU01030 APKU01146 APKU01819 APKU01247 APKU01448 APKU01449 APKU01450 APKU01451 APKU01452 APKU01453 APKU01556 APKU01557 APKU01558 APKU01559 APKU01560 APKU01561 APKU01562 APKU01563 APKU01564 APKU01565 APKU01566 APKU02001 APKU01290 APKU01291 APKU01292 APKU01293 APKU01702 APKU01703 APKU01157 APKU01222 APKU01223 APKU01233 APKU01314 APKU01315 APKU01316 APKU01317 APKU01318 APKU01816 APKU02015 APKU01089 APKU01881 APKU01882 APKU01883 APKU01884 APKU01885 APKU01886 APKU01610 APKU00994 APKU01606 APKU02152 APKU02350 APKU01497 APKU01498 APKU01499 APKU01500 APKU01788 APKU01145 APKU01211 APKU01212 APKU01213 APKU01214 APKU01319 APKU01555 APKU01791 APKU01795 APKU01796 APKU01797 APKU01423 APKU01028 APKU01143 APKU01144 APKU01173 APKU01874 APKU01875 APKU01876 APKU01877 APKU02107 APKU02108 APKU01622 APKU01626 APKU01627 APKU01799 APKU01815 APKU01150 APKU01151 APKU01219 APKU01220 APKU01770 APKU01771 APKU01787 APKU01287 APKU01337 APKU01794 APKU01871 APKU01215 APKU01216 APKU01217 APKU01764 APKU01903 APKU01184 APKU01198 APKU01768 APKU01286 APKU01792 APKU02148 APKU01230 APKU01767 APKU01205 APKU01879 APKU01728 APKU01323 APKU01821 APKU01822 APKU01823 APKU01824 APKU01843 APKU01844 APKU01845 APKU01846 APKU01847 APKU01848 APKU01956 APKU01957 APKU01958 APKU02127 APKU02183 APKU02184 APKU02185 APKU02186 APKU02187 APKU02188 APKU02189 APKU02190 APKU02191 APKU02192 APKU02193 APKU02194 APKU02195 APKU02196 APKU02197 APKU02198 APKU02199 APKU02200 APKU02201 APKU01102 APKU01103 APKU01104 APKU01105 APKU01236 APKU01420 APKU01421 APKU01422 APKU02003 APKU02004 APKU02005 APKU01313 APKU01052 APKU01054 APKU01177 APKU02323 APKU01252 APKU01253 APKU01254 APKU01250 APKU01251 APKU01623 APKU01624 APKU01625 APKU01055 APKU01056 APKU01057 APKU01255 APKU01256 APKU01257 APKU01259 APKU01260 APKU01261 APKU01262 APKU01263 APKU01264 APKU01175 APKU01176 APKU01297 APKU01298 APKU01710 APKU01321 APKU02231 APKU02232 APKU01950 APKU01741 APKU02214 APKU01301 APKU01302 APKU01303 APKU01304 APKU01299 APKU01300 APKU01781 APKU02325 APKU02326 APKU01338 APKU01234 APKU01235 APKU01793 APKU01758 APKU01654 APKU01655 APKU01075 APKU01322 APKU02123 APKU02124 APKU02125 APKU01786 APKU01644 APKU01645 APKU01154 APKU01873 APKU01616 APKU01993 APKU01553 APKU01199 APKU01305 APKU01306 APKU01307 APKU01308 APKU01309 APKU01310 APKU01311 APKU01312 APKU01085 APKU01086 APKU01087 APKU01088 APKU01110 APKU01267 APKU01898 APKU01899 APKU01900 APKU01901 APKU01902 APKU01428 APKU01429 APKU01492 APKU01908 APKU01487 APKU01488 APKU01489 APKU01490 APKU01491 APKU01592 APKU01628 APKU01629 APKU01630 APKU01632 APKU01633 APKU01045 APKU01058 APKU01585 APKU01586 APKU01046 APKU01155 APKU01196 APKU01197 APKU02290 APKU01147 APKU01148 APKU01149 APKU01493 APKU01494 APKU02233 APKU01179 APKU01474 APKU01475 APKU01476 APKU01769 APKU01232 APKU01642 APKU02330 APKU01248 APKU01484 APKU02153 APKU01156 APKU01495 APKU01161 APKU01501 APKU01496 APKU01078 APKU02149 APKU02150 APKU02151 APKU01061 APKU01486 APKU01700 APKU01483 APKU01818 APKU02155 APKU02156 APKU01880 APKU01249 APKU01949 APKU01567 APKU01477 APKU01478 APKU01479 APKU01320 APKU02165 APKU02166 APKU01059 APKU01944 APKU02113 APKU01166 APKU01612 APKU01762 APKU01763 APKU01272 APKU01273 APKU01485 APKU01947 APKU01132 APKU01643 APKU01111 APKU01125 APKU01126 APKU01127 APKU01129 APKU01130 APKU01131 APKU01133 APKU01134 APKU01135 APKU01825 APKU01826 APKU01827 APKU01828 APKU01829 APKU01945 APKU01946 APKU02033 APKU02034 APKU02035 APKU02293 APKU02294 APKU01022 APKU01128 APKU01274 APKU01275 APKU01276 APKU01277 APKU01278 APKU01279 APKU01280 APKU01281 APKU01282 APKU01283 APKU01284 APKU01714 APKU01715 APKU01716 APKU01923 APKU02114 APKU02115 APKU02329 APKU00973 APKU01221 APKU01229 APKU01605 APKU01185 APKU01186 APKU01187 APKU01188 APKU01189 APKU01190 APKU01191 APKU01192 APKU01193 APKU01194 APKU01074 APKU01789 APKU01790 APKU02007 APKU02008 APKU01860 APKU01861 APKU01862 APKU01863 APKU01864 APKU01865 APKU01866 APKU01867 APKU01868 APKU01869 APKU01870 APKU01549 APKU01554 APKU01162 APKU01887 APKU01888 APKU01481 APKU01482 APKU01651 APKU01652 APKU02209 APKU02210 APKU02211 APKU02212 APKU02213 APKU01590 APKU01591 APKU01695 APKU01808 APKU01809 APKU02324 APKU02327 APKU02328 APKU01341 APKU01445 APKU01446 APKU02317 APKU02318 APKU02319 APKU02320 APKU01047 APKU02009 APKU02010 APKU01800 APKU01801 APKU01802 APKU02351 APKU02356 APKU00974 APKU00975 APKU00976 APKU01578 APKU01060 APKU02287 APKU02288 APKU02289 APKU01073 APKU02006 APKU01020 APKU01114 APKU01115 APKU01116 APKU01117 APKU01118 APKU01119 APKU01120 APKU01121 APKU01122 APKU01123 APKU01798 APKU01803 APKU01804 APKU01761 APKU01759 APKU01760 APKU01994 APKU01995 APKU01996 APKU02321 APKU02322 APKU01593 APKU01594 APKU01595 APKU01596 APKU01597 APKU01598 APKU01076 APKU01077 APKU01339 APKU01340 APKU01805 APKU01806 APKU01922 APKU01999 APKU02000 APKU02202 APKU02203 APKU02204 APKU02205 APKU02206 APKU02207 APKU02208 APKU01206 APKU01207 APKU01208 APKU01209 APKU01225 APKU01226 APKU01227 APKU01228 APKU01288 APKU01289 APKU01889 APKU01890 APKU01891 APKU01892 APKU01893 APKU01894 APKU01895 APKU01896 APKU01897 APKU01523 APKU01524 APKU01525 APKU01526 APKU01522 APKU01653 APKU00868 APKU01439 APKU01440 APKU01441 APKU01442 APKU01443 APKU02154 APKU01285 APKU01599 APKU01600 APKU01601 APKU01602 APKU01603 APKU01604 APKU01031 APKU01032 APKU01807 APKU01106 APKU01107 APKU01611 APKU02011 APKU02012 APKU02013 APKU02014 APKU02278 APKU02279 APKU02280 APKU02281 APKU02282 APKU02283 APKU02284 APKU02285 APKU02286 APKU01782 APKU01783 APKU01258 APKU01271 APKU01907 APKU01989 APKU01990 APKU01991 APKU01992 APKU01109 APKU01294 APKU01295 APKU01296 APKU01748 APKU01749 APKU01750 APKU01751 APKU01752 APKU01753 APKU01920 APKU01921 APKU01927 APKU01928 APKU01939 APKU01940 APKU01941 APKU01942

Distribution pattern

Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.

device · product 6 of 6

Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 ASSY-MSN, VLV ASSY DR GAS CHK BCG, Manufacturing assembly - Buy 1503-3006-000 Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected and could have been installed on Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2 Anesthesia, and Amingo devices. (Service kit part numbers: 1009-8216-000, 1503-3006-000, 1503-8102-000, 1009-8423-000, 1503-8101-000).

Z-0682-2016
Recall number
Z-0682-2016
Initiated
December 15, 2015
Classification
Class II
Status
Terminated
Recalling firm
GE Medical Systems, LLC
Quantity
240

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

Code information

11328664 11335735 11343334 11343892 11342401-2 5400168 5403740-1 5403740-2 11335499 11345497 11340364 11320301-1 11320301-2 11330567 11331744 11307341 11331786 11335845 11335293 11319820 11321192 11321193 11327291 11322915 11332821 11326031 11330266 11313876 11331340 11304929 11336322 11336553 11315455 11325139 11326345 11335028-1 11335028-2 11305735 11322211 11323901 6514379 6514380 11307579 11307579 11321258 5398226 5405405 11337945 5404884 5405628 5406602 5401553-1 5401553-2 5402221-1 5402221-2 5402221-3 5404056-1 5404056-2 5404550-1 5404550-2 5404550-3 5404550-4 5405413-1 5405413-2 5405413-3 5405699-1 5405699-2 5405699-3 11009279 5405867 5405868 5398018-1 5398018-2 5404050-1 5404050-2 5405504-1 5405504-2 11320017 11324236 11311155 11342043 5401539 5401527-1 5401527-2 5401527-3 5401527-4 11315668 5401531 11334842 11305495 11333980 11339911 11330029-2 11308028 11323566 11323905 5406531 11334842 11305495 11333980 11339911 11330029-2 11308028 11323566 11323905 5406531

Distribution pattern

Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.