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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0755-2017

GE Healthcare, Avance, Avance CS2, Amingo.

Publicado el 21 de diciembre de 2016 · Inicio del retiro: 3 de noviembre de 2016

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Healthcare, LLC
Distribuidor
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
Lote
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 ANBK00
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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