GE Healthcare…

Date

Dec. 21, 2016

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Healthcare, Avance, Avance CS2, Amingo.

Reason

GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage drawer containing the optional large tray insert accessory closed with an abnormally high amount of force.

Distribution pattern

USA ( nationwide) Distribution including Puerto Rico and DC. and to the countries of Australia AUSTRIA Azerbaijan Bahrain Bangladesh Barbados Belarus Belgium BOLIVIA BOSNIA-HERZEGOVINA Brazil BRUNEI BULGARIA Canada CHILE China COLOMBIA COSTA RICA Croatia Cyprus Czech Republic Denmark ECUADOR Egypt Estonia Ethiopia Finland FRANCE Georgia GERMANY Ghana Gibraltar GREECE HONG KONG HUNGARIA Iceland India Indonesia IRAQ Ireland Israel ITALY JAPAN JORDAN KAZAKHSTAN Kenya KOREA, REPUBLIC OF Kuwait Latvia Lebanon Libyan Arab Jamahiriya LITHUANIA MACEDONIA MALAYSIA Malta Mexico MOLDOVA MOROCCO NAMIBIA Netherlands New Zealand Nicaragua Nigeria NORWAY Oman Pakistan Panama PARAGUAY PERU PHILIPPINES Poland PORTUGAL Qatar ROMANIA Russian Federation Saudi Arabia Serbia SERBIA-MONTENE Singapore Slovakia SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND SYRIA TAIWAN Thailand Tunisia TURKEY Ukraine United Arab Emirates UNITED KINGDOM Uruguay UZBEKISTAN Venezuela VietNam Yemen

Quantity

23,098 (US = 8,711; OUS = 14,387)

Codes and lots

FMI 34079 Initial Consignee List Mfg. Lot or Serial # ANBM00775 ANBM00776 ANBM00779 ANBN00775 ANBR01060 APKS01034 APKT00107 APKT02107 APKU00169 APKU00170 APKU00171 APKU01696 APKU01697 APKU01698 APKU01699 APKV00455 APKV00456 APKV00457 APKV00458 ANBH00259 ANBP00673 ANBP01851 ANBP02120 ANBP02121 APKS01352 APKS01353 APKS01354 APKS01355 APKS01356 APKT02322 APKT02323 APKT02324 APKT02325 APKT02326 APKV01600 APKV01601 APKV01602 APKV01554 APKV01555 APKV01556 APKV01557 APKV01558 APKV01559 APKV01560 APKV01561 APKV01562 APKV01198 APKV01199 APKV01200 APKV01201 ANBQ01418 ANBQ01419 ANBQ01420 ANBQ01421 ANBR01342 APKV00450 APKV00451 ANBM00230 ANBM00273 ANBM00497 ANBR00289 ANBR00290 ANBR00291 ANBR00292 ANBR00293 ANBR00294 ANBR00295 APKV01885 APKV01210 APKV01211 APKV00205 APKV00206 APKV00207 APKV00208 APKV00209 APKV00210 APKV00211 APKV00212 APKV00213 APKV00214 APKU00134 APKU00135 ANBQ01520 ANBQ01521 ANBQ01522 ANBQ01523 ANBQ01524 ANBQ02209 ANBQ02210 ANBQ02211 ANBQ02212 ANBQ02213 ANBS00535 ANBR01078 ANBR01079 ANBR01080 ANBK00957 APKU02425 APKU02426 APKU02427 APKU02428 APKU02429 APKU02430 APKU02431 APKU02432 ANBL01069 ANBP01486 ANBP01487 ANBP01488 ANBP01489 ANBP01490 ANBP01491 ANBP01492 ANBP01493 ANBN00773 ANBN00774 ANBN00791 ANBN00797 ANBN00798 ANBN00799 ANBN00800 ANBN00634 ANBN00921 ANBN00922 ANBN00923 ANBN00925 ANBN00926 ANBN00927 ANBN00928 ANBN00929 ANBN00930 ANBN00931 ANBN00932 ANBN00945 ANBN00946 ANBP01359 APKU01872 ANBR01053 ANBR01054 APKV01598 ANBN00633 ANBQ01015 ANBP00529 ANBP00530 ANBP00531 ANBQ01480 ANBQ01484 ANBQ01965 ANBQ01966 ANBS00304 ANBS00305 APKT00144 APKT02991 ANBN01391 ANBP01331 ANBN01672 ANBN01673 APKT02494 APKT02495 APKT02496 APKU00698 APKU00699 APKU00700 APKS01106 APKS01107 APKS01108 APKS01109 APKS01110 ANBJ01449 ANBJ01450 ANBK00679 ANBK00680 ANBM00539 ANBP01113 ANBP01114 ANBP01115 ANBP01116 ANBP01117 ANBP01118 ANBP01119 ANBQ01751 ANBR00248 APKT00754 APKT02383 APKV00943 APKV00944 APKV01877 APKV01878 ANBP01648 ANBP01649 ANBK00674 ANBK00743 ANBK00953 ANBN00512 ANBN00529 ANBN00531 APKU01237 APKU01238 APKU01239 APKU01240 APKU01241 APKU01242 APKU01243 ANBQ01051 ANBQ01052 ANBQ01053 ANBQ01054 ANBQ01055 ANBQ01056 APKT02006 APKT02007 APKT02008 APKT02009 ANBK00479 ANBL01159 ANBN01631 ANBM00538 ANBM00545 ANBM00547 ANBM00548 ANBM00549 ANBM00550 ANBM00551 ANBM00553 ANBP01361 ANBP01362 ANBP01363 ANBP02093 ANBP02094 ANBQ00785 ANBQ00786 APKU00936 APKU00937 APKU02395 APKU02396 APKU02397 APKU02398 ANBL01655 ANBL01656 ANBL01666 ANBL01705 APKT03236 APKT03237 ANBQ01258 ANBQ01259 ANBN00788 ANBN00789 ANBR00256 APKV01596 APKV01597 ANBP02185 ANBN01293 ANBM00709 ANBM01293 ANBN00155 ANBP00802 APKS00537 APKS00538 APKT02150 APKT02151 APKU01569 APKU01570 APKU02074 ANBM00947 ANBQ00109 ANBQ01041 APKV01385 ANBM01392 ANBP02152 ANBP02153 ANBP02154 ANBR02304 ANBR02305 ANBR02306 ANBR02307 APKU01701 ANBM00176 ANBM00177 ANBM00178 ANBM00179 ANBM00180 ANBM00181 ANBM00182 ANBM00183 APKT00806 APKT02120 APKV01169 APKU00679 ANBK00464 ANBK01214 ANBK01215 ANBK01216 ANBR00580 ANBR00581 ANBK01272 ANBK01273 ANBJ00140 ANBJ00141 ANBJ00733 ANBL01154 ANBN00105 ANBN00108 ANBN01398 ANBP00590 APKU01427 ANBP00736 ANBP00742 ANBM01064 ANBM01065 ANBM00171 ANBM00174 ANBP01683 ANBP01684 APKU01694 APKV01246 APKV01247 ANBM01303 ANBM01314 ANBP01623 ANBP01624 ANBP01625 ANBL00342 APKT00506 APKT00508 ANBR00604 ANBR00605 ANBR00606 ANBR00607 ANBR00608 ANBR00609 ANBR00610 ANBR00666 ANBR01525 APKT00892 APKU00600 ANBM00241 ANBM00244 ANBM00245 ANBM00328 ANBM00350 ANBM00352 ANBM01321 ANBM01322 ANBM01348 ANBM01351 ANBN01248 ANBN01249 ANBN01395 ANBN01674 ANBN01675 APKV00427 APKS00356 APKV00401 ANBP00735 ANBP00739 ANBP00741 ANBP00743 ANBM00959 ANBK00668 ANBK00729 ANBM00961 APKS01190 APKS01191 APKS01192 APKS01193 ANBR00145 ANBR00148 ANBR00142 ANBR00143 ANBR00144 ANBR00146 ANBR00147 ANBR00149 ANBR00150 ANBN01018 ANBQ01244 ANBQ01245 ANBQ01246 ANBQ01247 ANBQ01248 ANBQ01408 ANBQ01409 ANBQ01410 ANBQ01411 ANBQ01412 ANBQ01413 ANBJ01099 ANBJ01100 APKS00892 APKS00893 APKS00894 APKS00895 APKS00896 APKS00897 APKT02536 APKT00893 APKT00894 APKT00895 APKT00896 APKT00897 APKT00898 ANBK00646 ANBK00647 ANBK00648 ANBK00649 ANBK00650 APKV01014 APKV01015 ANBK00690 ANBK00691 ANBK00692 ANBK00693 ANBK00110 ANBK00111 ANBN01109 ANBK00109 ANBK00764 ANBM00621 ANBN01236 ANBN01237 ANBN01238 ANBN01253 ANBN01254 ANBN01264 ANBK01149 ANBK01150 ANBM00474 ANBM00475 ANBM01950 ANBM01951 ANBM01952 ANBM01953 ANBR01629 ANBR01689 ANBR01690 ANBK01218 ANBK01219 APKS01449 ANBP01594 ANBP01595 ANBP01811 ANBP01812 ANBP00867 ANBP00868 ANBP00869 ANBP00870 ANBP00871 ANBP00872 ANBP00873 ANBP00243 ANBP00244 ANBP00245 ANBP00316 APKU02163 APKU02164 ANBR01090 ANBR01091 ANBR01092 ANBR01093 ANBR01094 ANBR01095 ANBR01096 ANBR01097 ANBR01098 ANBR01099 ANBR01100 ANBR01101 ANBJ01355 ANBJ01356 ANBJ00677 ANBJ00679 ANBJ00691 ANBJ00724 ANBJ00725 ANBJ00729 ANBJ00730 ANBJ00743 ANBJ00744 ANBJ00745 ANBJ00746 ANBJ00747 ANBJ00748 ANBJ00749 ANBJ00750 ANBJ00751 ANBJ00752 ANBJ00753 ANBJ00754 ANBJ00755 ANBJ00756 ANBJ00757 ANBJ00758 ANBJ00759 ANBJ00760 ANBJ00761 ANBJ00762 ANBJ00763 ANBJ00764 ANBJ00765 ANBJ00766 ANBJ00779 ANBJ00780 ANBJ00781 ANBN00903 ANBN00904 ANBN00905 ANBN00906 ANBN00907 ANBN01092 ANBN01093 APKT02756 APKT02757 APKT02758 APKT02759 APKT02760 APKT02761 APKT02762 APKT02763 APKT02764 ANBK01197 ANBK01217 ANBK01244 ANBP01874 APKT00457 APKT00458 APKT00459 APKT00460 APKT00461 APKT00462 APKT00463 APKT00464 APKT00465 ANBN00410 ANBN00411 ANBN00441 ANBN00442 ANBQ01295 ANBQ01296 APKS01316 ANBL00311 ANBL00312 APKU00682 APKU01053 APKV00953 APKS00172 ANBP02102 ANBP02176 ANBP02177 ANBP02178 ANBP02179 ANBP02180 ANBP02181 ANBP02182 ANBJ00830 ANBJ00831 ANBJ00832 ANBJ00833 ANBJ00834 ANBJ00835 ANBJ00837 ANBJ00838 ANBJ00839 ANBJ00841 APKT03304 APKV00460 ANBL00874 ANBL00694 ANBL01637 ANBQ01938 APKT02181 APKT02182 ANBP00315 ANBP00317 ANBP00318 ANBS00844 APKT02765 ANBL00111 ANBL00112 ANBL00603 ANBQ00719 ANBQ00720 ANBQ00721 ANBR01016 ANBR01017 APKV01206 APKV01207 APKV01208 ANBQ01174 ANBQ01175 ANBQ01177 ANBQ01178 ANBQ01179 ANBQ01180 ANBQ01585 ANBQ01587 ANBQ01711 ANBQ01712 ANBQ01714 ANBQ01715 ANBQ01716 APKU01200 APKU01201 APKU01202 APKU01203 APKU01204 ANBN01250 ANBR00526 ANBL02066 ANBL02067 ANBL02068 ANBL02069 ANBR00979 ANBR00980 ANBR00981 ANBR00982 ANBR00983 ANBR00984 ANBR00985 ANBR00986 ANBR00987 ANBR00988 ANBR00989 APKU01686 APKU01687 APKU01688 APKV00629 APKV01205 ANBQ01586 ANBQ01679 APKT00659 APKT00837 APKU03059 APKU03060 APKU03061 APKU03062 APKU03063 APKU03064 APKU03065 APKU03066 APKU03067 ANBH00269 ANBP01896 ANBS00111 ANBP00547 ANBP00548 ANBP00549 ANBP00551 ANBP00552 APKT00296 APKT00297 APKU01904 ANBQ00994 ANBQ00995 ANBQ00996 ANBP01365 ANBP01366 ANBP01367 ANBP01368 ANBP01369 ANBP01370 ANBP01371 ANBP01372 ANBP01373 ANBP01374 ANBP01375 ANBP01376 ANBP01377 ANBP01378 ANBP01379 ANBP01380 APKT03274 APKU00263 APKU00264 ANBQ00554 ANBQ00555 ANBQ00811 ANBS00551 ANBS00609 ANBS00859 ANBS00860 ANBS00861 ANBS00862 ANBS00863 ANBS01311 ANBS01312 ANBN00462 ANBN00467 ANBN00565 ANBN00461 ANBL00852 ANBR01027 ANBR01028 APKS00612 APKS01047 APKS01048 APKT02121 APKT02122 ANBJ01059 ANBJ01124 ANBJ01144 ANBJ01145 APKS01457 APKT00449 APKT00450 APKU01810 APKV00941 APKU01447 ANBJ00174 ANBJ00176 ANBL00167 ANBR01634 ANBR01635 ANBR01636 ANBS00266 APKT02677 APKS01073 APKT00444 APKT00445 APKT00446 APKT00447 APKT00448 ANBK00481 ANBP01496 ANBK00742 ANBQ01078 ANBK00702 ANBK00703 ANBK00704 ANBK00706 ANBK00707 ANBS00315 ANBS00317 ANBS00248 ANBS00249 ANBS00316 ANBS01313 ANBJ00836 ANBJ00840 ANBL01467 ANBP01552 ANBP01553 ANBP01554 ANBL00521 ANBK00884 ANBK00889 ANBK00890 ANBK00892 ANBK00893 ANBK00894 ANBK00895 ANBK00896 ANBK00897 ANBK00898 ANBK00899 ANBK00900 ANBK00904 ANBK00905 ANBK00906 ANBK00907 ANBK00908 ANBK00909 ANBK00910 ANBK00911 ANBL01469 ANBL01470 ANBM00586 ANBM00588 ANBM00590 ANBM00591 ANBM00622 ANBS00322 ANBT00540 ANBT00541 ANBT00542 ANBT00543 ANBT00544 ANBT00545 ANBT00546 ANBT00547 ANBT00549 ANBT00550 ANBN00121 ANBL00263 ANBL00264 ANBL00265 ANBL00266 ANBL00267 ANBQ00704 ANBQ00706 ANBQ00709 ANBQ01424 ANBJ01387 APKS01267 APKS01268 ANBK00112 APKT00690 APKT00691 APKT00692 APKT00693 APKT00694 ANBK00705 ANBL01130 ANBL01131 ANBM00999 ANBQ01974 APKT00466 APKU00681 ANBM00317 ANBM01886 ANBM01887 ANBN01655 ANBQ00544 ANBQ00545 ANBR00569 ANBR00570 ANBR00574 ANBR00575 APKU02507 ANBM00232 ANBM00233 ANBM00252 ANBM00253 ANBM00254 ANBM00255 ANBM00256 ANBM00257 ANBR01717 ANBR01718 ANBR01719 ANBR01720 ANBR01721 ANBS00158 APKS01459 APKS01460 APKS01461 APKS01462 APKS01463 APKS01464 APKT03283 APKT03284 ANBP02158 ANBP02159 ANBP02160 ANBK01041 ANBL00477 ANBL00911 ANBL00912 ANBL00913 ANBL00926 ANBL00927 ANBL00928 ANBL00929 ANBL00930 ANBL00931 ANBL00932 ANBL00933 ANBL00934 ANBL00935 ANBQ01956 ANBQ01961 APKU01742 APKU01743 APKU03038 APKU03039 ANBQ01114 ANBQ01582 ANBQ01583 APKS01369 APKS01370 APKT00314 APKU00287 APKU00288 APKU00289 APKU00942 APKU00943 APKU01656 APKU01657 APKU01658 APKU01682 APKU01683 APKU01684 APKU01685 APKU00671 APKU00672 APKU00673 APKS00526 ANBR01038 APKT00838 ANBN01233 ANBN01234 ANBN01235 ANBN01547 ANBN01548 ANBP01105 ANBP01106 ANBP01107 ANBP01108 ANBP01109 ANBP01110 ANBP01582 ANBP01583 ANBQ01152 ANBR01024 ANBR01025 ANBR01026 ANBS00109 ANBS00110 APKU02966 APKU02967 APKV00935 APKV01563 APKV01564 APKV01565 APKV01566 APKV01567 APKV01568 APKV01569 APKV01570 APKV01571 APKV01572 APKV01573 APKV01574 APKV01575 APKV01576 ANBQ00920 ANBQ00921 ANBQ01142 ANBQ01143 ANBQ01144 ANBQ01145 ANBQ01146 ANBQ01147 ANBQ01148 ANBQ01149 ANBQ01150 APKT03280 APKS00278 APKS00279 APKS00280 APKS00362 APKS00363 APKS00365 APKS00366 APKS00367 APKS00375 APKS00376 APKS00377 APKS00378 APKS00379 APKS00384 APKS00390 APKS00391 APKS00392 APKS00393 APKS00394 APKS00396 APKS00397 APKS00398 APKS00415 APKS00416 APKS00417 APKS00418 APKS00419 APKS00420 APKS00626 APKS00627 APKS00628 APKS00629 APKS00630 APKS00631 APKS00632 APKS00633 APKS00634 APKS00635 APKS01002 APKU00196 APKU00197 APKU00198 APKU00760 ANBL01036 ANBL01037 ANBM00289 APKU00938 APKU01729 APKU01730 APKU01731 APKV00416 APKU01460 APKU01463 APKU01469 APKU01470 APKU01473 APKU01454 APKU01455 APKU01456 APKU01457 APKU01458 APKU01459 APKU01461 APKU01462 APKU01464 APKU01465 APKU01466 APKU01467 APKU01468 APKV00586 APKV00587 APKV00588 APKV00589 APKV00590 APKV00591 APKV00592 APKV00593 APKV00594 APKV00595 APKV00596 APKV00597 APKV00598 APKV00599 APKV00600 ANBL01646 APKS01003 APKS01004 APKS01005 APKS01006 APKS01007 APKR00140 APKS00165 APKS00167 APKS00170 APKS00275 APKS00276 APKS00277 APKS00717 APKS00725 APKU01378 APKU01379 APKU01380 APKU01381 APKU01382 APKU01383 APKU01384 APKU01385 APKS00284 APKS00285 ANBN00308 ANBN00309 ANBN00333 ANBN00334 APKS00272 APKU00103 APKU00105 APKU00106 APKU00107 APKU00108 ANBJ01456 APKT00801 APKT00802 APKV00928 APKV00929 APKU01021 ANBN01112 APKS00613 APKS00615 ANBQ00571 ANBQ00572 ANBQ00573 ANBQ00574 ANBQ00575 ANBQ00576 ANBQ00577 ANBQ00578 ANBQ00579 ANBQ00580 ANBQ00581 ANBQ00582 ANBQ00583 ANBQ00584 APKU02686 ANBM01417 ANBM01422 ANBM01424 ANBM01954 ANBM01955 ANBM01956 ANBM01957 ANBM01958 ANBN00377 ANBN00378 ANBN00386 ANBN00387 ANBP01849 ANBR01800 ANBL01242 ANBL01243 ANBL01244 ANBM00366 ANBR01759 ANBR01760 ANBR01761 ANBR01762 ANBL01041 ANBL01042 ANBL01043 ANBL01044 ANBL01045 ANBL01046 ANBL01047 ANBL01048 ANBL01049 ANBL01050 ANBL01051 ANBL01052 ANBL01053 ANBL01054 ANBL01055 ANBL01065 ANBL01070 ANBL01071 ANBL01072 ANBL01073 ANBL01074 ANBL01075 ANBL01076 ANBL01081 ANBL01082 ANBL01083 ANBL01084 ANBL01085 ANBL01086 ANBL01087 ANBL01088 ANBL01091 ANBL01092 ANBL01093 ANBL01094 ANBL01095 ANBL01096 ANBL01098 ANBL01099 ANBL01100 ANBL01101 ANBL01102 ANBL01103 ANBL01104 ANBL01105 ANBL01106 ANBL01107 ANBL01108 ANBL01109 ANBL01110 ANBL01111 ANBM01015 ANBM01016 ANBM01923 ANBM01924 ANBM01925 ANBM01926 ANBM01927 ANBM01928 ANBN00186 ANBP00685 ANBS00265 ANBM01830 ANBM01831 ANBM01832 ANBM01833 ANBM01834 ANBM01835 ANBM01836 ANBM01837 ANBM01838 ANBM01839 ANBM01840 ANBM01841 ANBM01842 ANBM01843 ANBM01844 ANBM01845 ANBM01846 ANBM01847 ANBM01848 ANBM01849 ANBM01850 ANBM01851 ANBM01852 ANBM01853 ANBM01854 ANBM01855 ANBM01856 ANBM01857 ANBM01858 ANBM01859 ANBM01860…

Recall started

Nov. 3, 2016

Device type

Gas-Machine, Anesthesia

Root cause (FDA)

Device Design

What the company told customers

GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 34079 dated November 3, 2016, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recall number

Z-0755-2017

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

Source: FDA · Medical device enforcement report, recall number Z-0755-2017. The agency record governs; check it and the company before acting.