FDAFDA · Food and drugs·Recall number Z-0009-2014
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Published October 23, 2013 · Recall initiated: September 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico except DE, ME, NM, RI, and VT, and the countries of UNITED ARAB EMIRATES, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA , MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION,SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED KINGDOM, VIETNAM, URUGUAY, and VENEZUELA.
- Lot
- Mfg Lot or Serial # ANBR01060 ANAQ01557 ANBQ01421 ANBQ01418 ANBQ01419 ANBQ01420 ANBR01342 ANBR00292 ANBR00289 ANBR00293 ANBR00290 ANBR00291 ANBR00294 ANBR00295 ANBQ01522 ANBQ01520 ANBQ01524 ANBQ01521 ANBQ01523 ANBQ02209 ANBQ02212 ANBQ02213 ANBQ02210 ANBQ02211 ANBS00535 ANBR01079 ANBR01078 ANBR01080 ANAQ00842 ANBR01053 ANBR01054 ANBQ01015 ANBQ01965 ANBQ01480 ANBQ01966 ANBQ01484 ANBS00304 ANBS00305 ANAR00675 ANAR05794 ANAR05793 ANBQ01751 ANBR00248 ANAS00596 ANAS00593 ANBQ01055 ANBQ01052 ANBQ01056 ANBQ01051 ANBQ01053 ANBQ01054 ANAQ01176 ANAQ01177 ANAR05091 ANAR05174 ANBQ00785 ANBQ00786 ANBR00256 ANBQ01664 ANBQ01259 ANBQ01258 APKS00537 APKS00538 ANAQ01781 ANBQ01041 ANBQ00109 ANBR02305 ANBR02304 ANBR02306 ANBR02307 ANAQ01376 ANAQ01377 ANAS00332 ANAS00331 ANAS01022 ANAS01024 ANAS01023 ANAS01019 ANAS01025 ANAS01016 ANAS01017 ANAS01020 ANAS01018 ANAS01021 ANAS01017 ANAS01022 ANAS01016 ANAS01018 ANAS01024 ANAS01019 ANAS01020 ANAS01021 ANAS01023 ANAS01025 ANBR00581 ANBR00580 ANAS00264 ANAP00948 ANAS00448 ANAR00952 ANAR00953 ANAR00955 ANAR00951 ANAR00954 ANAQ00470 ANAQ00510 ANAQ00511 ANAS00579 ANAQ00461 ANAQ00465 ANAQ00466 ANAQ00464 ANAQ00462 ANAQ00463 ANAQ00512 ANAQ00830 ANAQ00829 ANAQ00833 ANAQ00831 ANAQ00834 ANAQ00835 ANAQ00832 ANAQ01594 ANAR00232 ANAR00257 ANAR00254 ANAR00553 ANAR00558 ANAR05477 ANAR05476 ANAR05479 ANAR05478 ANAR05480 ANAR05481 ANAS00211 ANAS00628 ANBR00526 ANBR00609 ANBR00607 ANBR00604 ANBR00605 ANBR00608 ANBR00610 ANBR00606 ANBR01525 ANBR00666 APKS00356 ANAR00332 ANAR00331 ANBR00147 ANBR00142 ANBR00144 ANBR00145 ANBR00148 ANBR00150 ANBR00143 ANBR00149 ANBR00146 ANAS00569 ANAR00549 ANAR05005 ANAR05052 ANAR05053 ANAR05009 ANAR05054 ANAR05008 ANAR05004 ANAR05002 ANAR05006 ANAR05007 ANAR05003 ANBQ01248 ANBQ01247 ANBQ01245 ANBQ01244 ANBQ01246 ANBQ01412 ANBQ01409 ANBQ01408 ANBQ01410 ANBQ01411 ANBQ01413 ANAS00572 ANAS00574 ANAS00571 ANAS00575 ANAS00576 ANAQ01188 ANAR05265 ANAR05264 ANAR05610 ANAR05611 ANAS00204 ANAS00202 ANAS00203 ANAS00697 ANAS00698 ANAS00699 ANBR01689 ANBR01690 ANBR01629 ANAR05538 ANAR00421 ANBR01093 ANBR01097 ANBR01101 ANBR01092 ANBR01090 ANBR01091 ANBR01094 ANBR01098 ANBR01095 ANBR01096 ANBR01099 ANBR01100 ANAR05110 ANAR05108 ANAR05114 ANAR05109 ANAR05111 ANAR05113 ANAR05112 ANAR05115 ANBQ01295 ANBQ01296 ANAR00490 ANAR00491 ANAS01058 ANAS01059 ANAQ01488 ANAQ01491 ANAQ01489 ANAQ01490 ANAQ01492 ANAQ01785 ANAQ01784 ANBQ01674 ANBQ01672 ANBQ01673 ANBQ01938 ANAQ01514 ANAS00126 ANAS00131 ANAS00124 ANAS00121 ANAS00125 ANAS00130 ANAS00129 ANAS00123 ANAS00132 ANAS00127 ANAS00122 ANAS00128 ANBS00844 ANBQ00719 ANBQ00720 ANBQ00721 ANBR01017 ANBR01016 ANBR00979 ANBR00982 ANBR00989 ANBR00984 ANBR00986 ANBR00987 ANBR00985 ANBR00988 ANBR00980 ANBR00981 ANBR00983 ANBQ01679 ANBQ01586 ANBS00111 ANAP00691 ANBQ00995 ANBQ00996 ANBQ00994 ANAS00240 ANBQ00555 ANBQ00554 ANBQ00811 ANAQ01593 ANAS00609 ANAQ01385 ANAQ01383 ANAQ01378 ANAQ01379 ANAQ01381 ANAQ01384 ANAQ01382 ANAQ01380 ANAR06050 ANAR06053 ANAR06047 ANAR06049 ANAR06046 ANAR06045 ANAR06052 ANAR06048 ANAR06051 ANBR01028 ANBR01027 APKS00612 ANAQ01701 ANBR01634 ANBR01635 ANBR01636 ANBS00266 ANBS00315 ANBS00249 ANBS00317 ANBS00316 ANBS00248 ANBQ00709 ANBQ01424 ANBQ00706 ANBQ00704 ANBQ01974 ANAR05532 ANBQ00545 ANBQ00544 ANBR00570 ANBR00575 ANBR00574 ANBR00569 ANAR05217 ANAR05219 ANAR05216 ANAR05218 ANBR01720 ANBR01717 ANBR01721 ANBR01718 ANBR01719 ANBS00158 ANBP02158 ANBP02159 ANBP02160 ANAR05603 ANAR05602 ANAS00443 ANAS00446 ANAS00445 ANBQ01956 ANBQ01961 ANAR00692 ANAR00693 ANAS00325 ANAS00328 ANAS00329 ANAS00326 ANAS00327 ANAQ00469 APKS00526 ANBR01038 APKS00278 APKS00280 APKS00365 APKS00366 APKS00384 APKS00418 APKS0037
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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