GE Healthcare…

Date

Oct. 23, 2013

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.

Reason

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

Distribution pattern

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.

Quantity

10,263 (3,194 US, 7,069 OUS)

Codes and lots

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 APKS00375 APKS00379 APKS00394 APKS00396 APKS00419 APKS00363 APKS00391 APKS00420 APKS00367 APKS00377 APKS00416 APKS00390 APKS00393 APKS00362 APKS00376 APKS00378 APKS00397 APKS00417 APKS00415 APKS00392 APKS00398 APKS00279 ANBQ01152 ANBR01024 ANBR01026 ANBR01025 ANBS00109 ANBS00110 ANBQ00921 ANBQ00920 ANBQ01143 ANBQ01146 ANBQ01148 ANBQ01147 ANBQ01149 ANBQ01142 ANBQ01144 ANBQ01150 ANBQ01145 ANAS00814 ANAS00813 APKS00284 APKS00285 APKS00272 ANBQ00577 ANBQ00583 ANBQ00572 ANBQ00573 ANBQ00574 ANBQ00575 ANBQ00576 ANBQ00581 ANBQ00580 ANBQ00584 ANBQ00571 ANBQ00578 ANBQ00582 ANBQ00579 ANBR01800 ANBR01759 ANBR01761 ANBR01760 ANBR01762 ANBS00265 ANBP02188 ANBP02162 ANBQ00105 ANBQ00107 ANBQ00106 ANBQ00761 ANBQ00760 ANBR02068 ANBR02067 ANBR02066 APKS00475 ANBQ01220 ANBQ01103 ANBQ01101 ANBQ01102 ANBQ01106 ANBQ01104 ANBR01151 ANBR01150 APKS00230 APKS00226 APKS00229 ANAS00260 ANAS00340 ANAS00342 ANAS00344 ANAS00341 ANAS00343 ANAR00330 ANAR00602 ANAR00603 ANAS01091 ANAS01092 ANAS01090 ANAS01089 ANAP00779 ANAP00777 ANAP00778 ANAR00698 ANAR00697 ANBQ00602 ANBQ00601 ANBR00799 ANBR00798 ANBR01088 ANBR01089 ANBR00527 ANBS00169 ANBS00171 ANBS00170 ANBQ01927 ANBQ01926 ANAP01159 ANBR01841 ANBS00209 ANBS00206 ANBS00207 ANBS00208 ANBR02069 ANBR02072 ANBR02071 ANBR02070 ANBR02358 ANBQ00589 ANBQ00590 ANBQ00587 ANBQ00588 ANBQ00693 ANBQ00692 ANBR00816 ANBR00817 ANBR00815 ANBR00814 ANBR00818 ANAR06031 ANAR06033 ANAR06036 ANAR06027 ANAR06030 ANAR06028 ANAR06029 ANAR06032 ANAR06034 ANAR06035 ANBQ01075 ANBQ01076 ANBQ01761 ANBQ01758 ANBQ01757 ANAR06025 ANAR06026 ANAQ00566 ANAS00265 APKS00543 APKS00540 APKS00542 APKS00541 APKS00544 APKS00545 APKS00528 APKS00527 APKS00495 ANBR00646 ANBR00649 ANBR00651 ANBR00650 ANBR00665 ANBR00643 ANBR00622 ANBR00620 ANBR00644 ANBR00568 ANBR00626 ANBR00627 ANBR00642 ANBR00621 ANBR00625 ANBR00567 ANBR00624 ANBR00645 ANAS00695 ANBQ01789 ANBQ01790 ANBQ01786 ANBQ01787 ANBQ01788 ANBQ01743 ANBQ01744 ANBR01734 ANBR01733 ANBS00364 ANBS00340 ANBS00341 ANBS00363 ANBS00362 ANBR00646 ANBR00650 ANBR00651 ANBR00665 ANBR00649 ANBR00567 ANBR00627 ANBR00642 ANBR00643 ANBR00626 ANBR00621 ANBR00625 ANBR00620 ANBR00624 ANBR00644 ANBR00568 ANBR00622 ANBR00645 ANBR00672 ANBR00673 ANBR00671 ANBR00668 ANBR00669 ANAQ01792 ANAQ01794 ANAQ01796 ANAQ01788 ANAQ01795 ANAQ01790 ANAQ01789 ANAQ01791 ANAQ01787 ANAQ01793 ANAR00592 ANAR00598 ANAR00599 ANAR00595 ANAR00594 ANAR00597 ANAR00591 ANAR00593 ANAR00596 ANAR00600 ANAS00432 ANAS00428 ANAS00433 ANAS00431 ANAS00434 ANAS00430 ANAS00435 ANAS00429 ANBP02109 ANBP02196 ANBP02209 ANBP02210 ANBP02111 ANBP02112 ANBP02197 ANBP02208 ANBQ00100 ANBP02110 ANAS00444 ANBQ01231 ANBQ01230 ANBQ01232 ANBR02323 ANBR02334 ANBR02340 ANBR02335 ANBR00566 ANBR02336 ANBR02337 ANBR02338 ANBR02342 ANBR02343 ANBR00564 ANBR02339 ANBR00563 ANBR02341 ANBR00562 ANBR00548 ANBQ00636 ANBQ00637 ANBQ00817 ANBQ00818 ANBQ00819 ANBQ00816 ANBQ01710 ANBQ01814 ANBR01893 ANBR02419 ANBQ01260 ANBQ01366 ANBQ01362 ANBQ01363 ANBQ01367 ANBQ01365 ANBQ01364 ANBR00408 ANBQ01933 ANBR00407 ANBR01852 ANBR01853 ANBQ00213 ANBQ00214 ANBQ00210 ANBP02187 ANBP02186 ANBP02184 ANBQ00209 ANBQ00208 ANBQ00793 ANBQ00795 ANBQ00796 ANBQ00794 ANBQ00797 ANBQ01794 ANBQ01792 ANBQ01791 ANBQ01793 ANBQ01795 ANBR00921 ANBR00919 ANBR00920 ANBQ00614 ANBQ00613 ANBR00550 ANBR00551 ANBR00901 ANBR00900 ANBS00295 ANBS00296 ANBS00294 ANBQ00761 ANBQ00760 ANBS00546 ANBQ00212 ANBQ00211 ANBR00523 ANBR00525 ANBR00524 ANBQ00762 ANBR00750 ANBR00753 ANBR00752 ANBR00754 ANBR00751 ANAQ01071 ANAQ01070 ANAS00133 ANAS00986 ANAQ00555 ANBQ01968 ANBQ01967 ANAR05535 ANAR05534 ANAR05537 ANAR06014 ANAR06016 ANAR06019 ANAR06054 ANAR06017 ANAR06018 ANAR06015 ANBS00449 ANBQ01428 ANBQ01429 ANBQ01971 ANAR05654 ANAR05653 ANBR01586 ANBR01585 ANBR01588 ANBR01590 ANBR01583 ANBR01589 ANBR01593 ANBR01592 ANBR01580 ANBR01582 ANBR01584 ANBR01581 ANBR01587 ANBR01591 ANBQ01425 ANAQ01328 ANAQ01192 ANAQ01191 ANAQ01189 ANBQ00598 ANBQ00698 ANBQ00591 ANBQ00597 ANBQ00700 ANBQ00699 ANBQ01488 ANBQ01486 ANBQ01487 ANBQ01489 ANBR02354 ANBS00379 ANBQ00561 ANBQ00560 ANBQ00557 ANBQ00558 ANBQ00562 ANBQ00559 ANBQ00875 ANBQ00876 ANBQ01624 ANBQ01623 ANBR00571 APKS00477 ANBQ00184 ANBQ00605 ANBQ00182 ANBQ00181 ANBQ00183 ANBQ01876 ANBQ01878 ANBQ01879 ANBQ01877 ANBQ01880 ANAS00595 ANBR01235 ANBQ01441 ANBQ01442 ANBQ01675 ANBQ01677 ANBQ01676 ANBQ01701 ANBR01153 ANBR01811 ANBR01812 ANBR01005 APKS00502 APKS00503 APKS00504 APKS00501 ANBR02353 ANBR01011 ANBR01012 ANBR01013 ANBR01010 ANBR01058 ANBR01057 ANBR01056 ANBR01055 ANBR00685 ANBR00583 ANBQ02047 ANBQ02048 ANBQ02049 ANBQ02050 ANBQ02054 ANBQ02055 ANBQ02051 ANBQ02052 ANBQ02053 ANBQ02056 ANBR01443 ANBR01431 ANBR01440 ANBR01441 ANBR01433 ANBR01442 ANBR01434 ANBR01432 ANBR00231 ANBR00232 ANBR00233 ANBR00230 ANBR02224 ANBR02222 ANBR02223 ANBR02220 ANBR02221 ANBR00244 ANBR00243 ANBR00241 ANBR00242 ANBR00896 ANBR00898 ANBR00897 ANBR02224 ANBR02222 ANBR02223 ANBR02220 ANBR02221 ANBR01765 ANBR01766 ANBR01763 ANBR01764 ANBR01767 ANBR02378 ANBR02379 ANBR02381 ANBR02382 ANBR02380 ANBR00557 ANBR00558 ANBR02362 ANBR02363 ANBS00450 ANAQ00309 ANAQ00680 ANAQ00679 ANAR01025 ANAS00145 ANBQ00128 ANBR02407 ANBR02406 ANBR01838 ANBR01836 ANBR01837 ANBR01834 ANBR01839 ANBR01835 ANAQ00550 ANAQ00552 ANAP01160 ANAP01161 ANAQ00548 ANAP01163 ANAQ00553 ANAQ00554 ANAP01165 ANAQ00549 ANAP01164 ANAP01167 ANAP01162 ANAP01166 ANAR05353 ANAR05352 ANAS01096 ANBQ00596 ANBR02426 ANAR05563 ANAR05565 ANBQ00705 ANBQ00707 ANAQ00372 ANAQ00373 ANAQ00377 ANAQ00375 ANAQ00374 ANAQ00376 ANAR00157 ANAR00152 ANAR00154 ANAR00153 ANAR00156 ANAR00150 ANAR00151 ANAR00155 ANAR05255 ANAR05256 ANAR05069 ANAR05072 ANAR05071 ANAR05076 ANAR05073 ANAR05075 ANAR05068 ANAR05070 ANAR05074 ANBQ01746 ANBR01283 ANBR01286 ANBR01285 ANBR01284 ANBQ01569 ANBQ01571 ANBQ01572 ANBQ01570 ANBQ01573 ANBQ01568 ANBQ01957 ANBQ01959 ANBQ01958 ANBS00325 ANBR02425 ANBS00388 ANBR00716 ANBQ01669 ANBQ01668 ANBQ00178 ANBQ00111 ANBQ00164 ANBQ00112 ANBQ00113 ANBQ00179 ANBQ00177 ANBQ00180 ANBQ00165 ANBQ00922 APKS00529 ANBR00124 ANBR00125 ANBR02383 ANBR00554 ANBR00555 ANBR00556 ANBR00553 ANAQ00284 ANAQ00283 ANAS00440 ANBR00163 ANBR00164 ANAR05079 ANAR05078 ANBS00245 ANBP02163 ANBQ01293 ANBQ01294 ANBS00603 ANBS00604 ANAQ01346 ANAQ01349 ANAQ01350 ANAQ01372 ANAQ01371 ANAQ01347 ANAQ01348 ANAQ01375 ANAR05123 ANAR05117 ANAR05121 ANAR05119 ANAR05120 ANAR05122 ANAR05118 ANAQ00501 ANAQ00502 ANAQ00503 ANAQ00504 ANAR00169 ANAR00170 ANAR00171 ANAS00195 ANAS00513 ANBR02389 ANBR02387 ANBR02388 ANBQ01763 ANBQ01765 ANBQ01764 ANAS00150 ANAS00151 ANBQ00320 ANBQ00325 ANBQ00321 ANBQ00315 ANBQ00323 ANBQ00324 ANBQ00326 ANBQ00314 ANBQ00318 ANBQ00319 ANBQ00316 ANBQ00317 ANBQ00327 ANBQ00322 ANBQ00328 ANBR00595 ANBS00244 ANBQ01962 ANBQ00937 ANBQ00938 ANBQ01760 APKS00283 ANBQ00289 ANBQ00286 ANBQ00290 ANBQ00288 ANBQ00291 ANBQ00292 ANBQ00293 ANBQ00287 ANBQ00546 ANBQ00547 ANBQ00548 ANBS00241 ANBS00242 ANBQ01430 ANBR02428 ANBR02427 ANBR00593 ANAR00630 ANAR00634 ANAR00629 ANAR00633 ANAR00632 ANAR00631 ANBQ01671 ANBQ01670 ANBR00947 APKS00606 APKS00607 APKS00605 ANAQ00334 ANAQ00333 ANAN00960 ANAQ00331 ANAN00961 ANAQ00330 ANAQ00332 ANAR00238 ANAR00239 ANAR00237 ANAR00240 ANAR00250 ANAR00241 ANAR05085 ANAR05086 ANAR05084 ANAR05087 ANAR05083 ANAR05855 ANAR05077 ANAR05560 ANAR05562 ANAR05561 ANBQ01813 ANBQ01810 ANBQ01811 ANBQ01812 ANBR02384 ANBR02385 ANBR02235 ANBQ01351 ANBQ01354 ANBQ01355 ANBQ01352 ANBQ01353 ANBQ01350 ANBR01737 ANBR01738 ANBR01739 ANBR01740 APKS00457 APKS00454 APKS00456 APKS00458 APKS00460 APKS00455 APKS00459 APKS00461 ANBR01008 ANBR01009 ANBR01007 ANAR00337 ANBQ00703 ANAQ00674 ANAQ00673 ANBQ01532 ANBQ01659 ANBQ01529 ANBQ01530 ANBQ01658 ANBQ01660 ANBQ01531 ANBQ01848 ANBQ01525 ANBQ01527 ANBQ01528 ANBQ01853 ANBQ01856 ANBQ01526 ANBQ01661 ANBQ01852 ANBQ01857 ANBQ01851 ANBQ01849 ANBQ01850 ANBQ01855 ANBQ01953 ANBR02302 ANBQ01360 ANBQ01359 ANBQ00108 ANBQ01766 APKS00359 APKS00364 ANAS01011 ANAS01032 ANAS01033 ANAS01049 ANAS01046 ANAS01015 ANAS01027 ANAS01030 ANAS01041 ANAS01042 ANAS01043 ANAS01006 ANAS01007 ANAS01013 ANAS01026 ANAS01034 ANAS01040 ANAS01012 ANAS01036 ANAS01052 ANAS01038 ANAS01047 ANAS01008 ANAS01009 ANAS01029 ANAS01035 ANAS01044 ANAS01045 ANAS01014 ANAS01028 ANAS01048 ANAS01050 ANAS01051 ANAS01039 ANAS01010 ANAS01031 ANAS01037 ANBQ00882 ANBQ01027 ANBQ01026 ANBQ00997 ANBQ00998 ANBQ01577 ANBQ01530 ANBQ01659 ANBQ01529 ANBQ01532 ANBQ01531 ANBQ01658 ANBQ01660 ANBQ01851 ANBQ01853 ANBQ01857 ANBQ01849…

Recall started

Sept. 16, 2013

Device type

Gas-Machine, Anesthesia

Root cause (FDA)

Software design

What the company told customers

Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated September 17, 2013. The letter was addressed to Chief of Anesthesia, Health Care Administrator / Risk Manager, and Director of Biomedical / Clinical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US call 1 800-345-2700, for other countries contact your local GE Healthcare Service Representative).

Recall number

Z-0009-2014

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

Source: FDA · Medical device enforcement report, recall number Z-0009-2014. The agency record governs; check it and the company before acting.