Reported Oct 23, 2013 · Terminated
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control…
GE Healthcare, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
- Lot codes and dates
- Mfg Lot or Serial #- 1 APHS00844 APHS00711 APHS00712 5324664 - 1 APHS00703 APHS00704 5328496 - 1
APHS00701APHS00802APHS00729APHS00730APHS00700APHS00692APHS00932APHS00886APHS00861APHS00865APHS00866APHS00867APHS00868APHS00887APHS00888APHS00860APHS0088170138420
- 1 5324910 - 1 5324910 - 2 5324910 - 3 5324910 - 4 5324910 - 5 5324911 - 1 5325677 - 1 5325677 - 10 5325677 - 11 5325677 - 12 5325677 - 13 5325677 - 14 5325677 - 15 5325677 - 16 5325677 - 17 5325677 - 2 5325677 - 3 5325677 - 4 5325677 - 5 5325677 - 6 5325677 - 7 5325677 - 8 5325677 - 9 5326146 - 1 5326146 - 2 5326146 - 3 5326146 - 4 5326146 - 5 5326146 - 6 5326146 - 7 5326146 - 8 5327169 - 1 5327169 - 2 5327169 - 3 5327169 - 4 5327169 - 5 5327169 - 6 5327288 - 1 5327288 - 2 5327288 - 3 5329262 - 1 5329262 - 10 5329262 - 11 5329262 - 12 5329262 - 13 5329262 - 14 5329262 - 15 5329262 - 16 5329262 - 17 5329262 - 18 5329262 - 19 5329262 - 2 5329262 - 3 5329262 - 4 5329262 - 5 5329262 - 6 5329262 - 7 5329262 - 8 5329262 - 9 ANAS01053 ANAS01054 5325959 - 1 5325959 - 10 5325959 - 11 5325959 - 12 5325959 - 13 5325959 - 2 5325959 - 3 5325959 - 4 5325959 - 5 5325959 - 6 5325959 - 7 5325959 - 8 5325959 - 9 5326782 - 1 5326782 - 2226 of 226 codes
APHS00690APHS00719APHS00720APHS00722APHS00723APHS00828APHS00834APHS00835APHS00836APHS00843APHS00809APHS00854APHS00855APHS00856APHS00857APHS00858APHS00691APHS00702APHS00705APHS00721APHS00807APHS00808APHS00811APHS00685APHS00695APHS00696APHS00697APHS00698APHS00699APHS00805APHS00806APHS00812APHS00810APHS00864APHS00643APHS00644APHS00645APHS00646APHS00647APHS00648APHS00649APHS00650APHS00651APHS00652APHS00653APHS00654APHS00655APHS00656APHS00657APHS00666APHS00667APHS00731APHS00732APHS00733APHS00734APHS00735APHS00736APHS00737APHS00738APHS00739
- 1 5323856 - 2 5323856 - 3 5323856 - 4 5323856 - 5 5323856 - 6 5327897 - 1 5327897 - 2ANAS00922ANAS00932ANAS00923ANAS00924ANAS00900ANAS00905ANAS00935ANAS00936ANAS00937ANAS00938ANAS00939ANAS00940ANAS00941ANAS00942ANAS00943ANAS00944ANAS009455323856
- 1 5324418 - 2 5324418 - 3 5324492 - 1 5325318 - 1 5325318 - 2 ANAS00964 ANAS00965 5324012 - 1 5324012 - 2 5324012 - 3 5324672 - 1ANAS00967ANAS00968ANAS00969ANAS00970ANAS00972ANAS00973ANAS00974ANAS00975ANAS00976ANAS00977ANAS00978ANAS00979ANAS00981ANAS00982ANAS00983ANAS00984ANAS00985ANAS00997ANAS00998ANAS00906ANAS00993ANAS009095324418
- 1 ANAS00800 ANAS00989 ANAS00990 5324604 - 1 5327482 - 1 5327482 - 2 5328933 - 1ANAS00925ANAS00926ANAS00950ANAS00951ANAS00952ANAS00953ANAS00966ANAS00971ANAS009915326891
- 1 70130790 - 2 70131952 - 1 70131952 - 2 70131952 - 3 70131952 - 4 70131952 - 5 70131952 - 6 70131952 - 7 70131952 - 8 70132184 - 1 70132184 - 2 70132184 - 3 70132184 - 4 70132184 - 5 70132537 - 1 70132537 - 1 70132537 - 2 70132537 - 2 70132537 - 3 70132619 - 1 70132619 - 2 70132619 - 3 70132619 - 4 70132619 - 5 70132619 - 6 70133381 - 1 70133381 - 2 70133381 - 3 70133381 - 4 70133381 - 5 70133381 - 6 70133381 - 7 70134330 - 1 70134330 - 2 70134330 - 3 ANBS00606 ANBS00687 ANBS00326 5321204 - 1 5321204 - 2 5321204 - 3 5322929 - 1 5322929 - 10 5322929 - 11 5322929 - 12 5322929 - 13 5322929 - 14 5322929 - 15 5322929 - 16 5322929 - 17 5322929 - 18 5322929 - 19 5322929 - 2 5322929 - 20 5322929 - 21 5322929 - 3 5322929 - 4 5322929 - 5 5322929 - 6 5322929 - 7 5322929 - 8 5322929 - 9 5324558 - 1 5326594 - 1 5326594 - 2 5328365 - 1 5328365 - 2 5328365 - 3 5328480 - 1 5328480 - 2 5329188 - 1 5329245 - 1 5329245 - 2 5329437 - 1 5329437 - 10 5329437 - 11 5329437 - 12 5329437 - 13 5329437 - 2 5329437 - 3 5329437 - 4 5329437 - 5 5329437 - 6 5329437 - 7 5329437 - 8 5329437 - 9ANAS00907ANAS00934ANAS01055ANAS00276ANAS00787ANAS00933ANAS00333ANAS00386ANAS01004ANAS00994ANAS00995ANAS00996ANAS00946ANAS00947ANAS00948ANAS00949ANAS00954ANAS00955ANAS00956ANAS00957ANAS00992ANBS00603ANBS00604ANBS00800ANBS00602ANBS0037070130790
- 1 5325323 - 1 5325323 - 2 5325323 - 2 5328054 - 1 5328054 - 2 5328054 - 3 5328054 - 4 5328054 - 5 5328054 - 6ANBS00748ANBS00697ANBS00698ANBS00699ANBS00780ANBS00781ANBS00782ANBS007835325323
- 1 5329651 - 1 ANBS00681 ANBS00686 ANBS00710 5329692 - 1 5329692 - 2 5329692 - 3ANBS00754ANBS00693ANBS00694ANBS00695ANBS00696ANBS00701ANBS00702ANBS00703ANBS00704ANBS00713ANBS00714ANBS00715ANBS00716ANBS00717ANBS00718ANBS00719ANBS00720ANBS00721ANBS00761ANBS00762ANBS007985329715
- 1 5297658 - 1 5297658 - 2 5324971 - 1 5324971 - 10 5324971 - 2 5324971 - 3 5324971 - 4 5324971 - 5 5324971 - 6 5324971 - 7 5324971 - 8 5324971 - 972 of 72 codes
ANBS00755ANBS00757ANBS00758ANBS00759ANBS00733ANBS00734ANBS00735ANBS00617ANBS00770ANBS00771ANBS00779ANBS00769ANBS00737ANBS00738ANBS00739ANBS00740ANBS00741ANBS00742ANBS00743ANBS00744ANBS00745ANBS00746ANBS00672ANBS00705ANBS00706ANBS00707ANBS00708ANBS00709ANBS00722ANBS00768ANBS00801ANBS00684ANBS00685ANBS00711ANBS00712ANBS00723ANBS00724ANBS00725ANBS00726ANBS00727ANBS00728ANBS00729ANBS00730ANBS00731ANBS00732ANBS00772ANBS00773ANBS00774ANBS00775ANBS00776ANBS00777ANBS00778ANBS00784ANBS00785ANBS00786ANBS00787ANBS00788ANBS00789ANBS00790ANBS00736
- 1 CBCS00963 CBCS01100 5324655 - 1 5324727 - 1 5325591 - 1 5325591 - 2 5325591 - 3 5326544 - 1 5326544 - 2 5326544 - 3 5326544 - 4 5326547 - 1 5326547 - 2 5326652 - 1 5326742 - 1 5326852 - 1 5326852 - 10 5326852 - 11 5326852 - 12 5326852 - 13 5326852 - 14 5326852 - 15 5326852 - 16 5326852 - 17 5326852 - 18 5326852 - 19 5326852 - 2 5326852 - 20 5326852 - 21 5326852 - 22 5326852 - 23 5326852 - 24 5326852 - 25 5326852 - 26 5326852 - 3 5326852 - 4 5326852 - 5 5326852 - 6 5326852 - 7 5326852 - 8 5326852 - 9 5326889 - 1 5326993 - 1 5326993 - 2 5327620 - 1 5327620 - 2 5327620 - 3 5327620 - 4 5327853 - 1 5327853 - 2 5327853 - 3 5328021 - 1 5328021 - 2 5328409 - 1 5328409 - 2 5328627 - 1 5328707 - 1 5328707 - 2 5328707 - 3CBCS00965CBCS00968CBCS00969CBCS00970CBCS00971CBCS00972CBCS00973CBCS00974CBCS00976CBCS00977CBCS00979CBCS00981CBCS00982CBCS00983CBCS011775326925
- 1 5324756 - 1 5324756 - 2 5325311 - 1 5326690 - 1 5326690 - 2 5326692 - 1 5326693 - 1 5326693 - 2 5326698 - 1 5326698 - 2 5326700 - 1 5320342 - 1 5320342 - 2 5320342 - 3 5320342 - 4 5320342 - 5 5325257 - 1 5325257 - 2 5325257 - 3 5325257 - 4 5325257 - 5 5325257 - 6CBCS01026CBCS01027CBCS01028CBCS01029CBCS01030CBCS01031CBCS01032CBCS01033CBCS01034CBCS01035CBCS01036CBCS01037CBCS01038CBCS01039CBCS01040CBCS01041CBCS01042CBCS01043CBCS01044CBCS01045CBCS01046CBCS01047CBCS01048CBCS01050CBCS01052CBCS01053CBCS01054CBCS01056CBCS01057CBCS01058CBCS01062CBCS01063CBCS01064CBCS01065CBCS01066CBCS01067CBCS01068CBCS01070CBCS01071CBCS01123CBCS01124CBCS01133CBCS01136CBCS011385323487
- 1CBCS00964CBCS00967CBCS01181CBCS01196CBCS01197CBCS01198CBCS01199CBCS01200CBCS01201CBCS01202CBCS01203CBCS01132CBCS00957CBCS00958CBCS01089CBCS01090CBCS01148CBCS01149CBCS01151CBCS01152CBCS01153CBCS01154CBCS01155CBCS01156CBCS01157CBCS01158CBCS01160CBCS01161CBCS01162CBCS01163CBCS01164CBCS01168CBCS01135CBCS01165CBCS01166CBCS01167CBCS01169CBCS01091CBCS01092CBCS01093CBCS01094CBCS01095CBCS01096CBCS01097CBCS01098CBCS010995329011
- 1 CBCS01061 5325609 - 1 5325609 - 2 5325609 - 3CBCS00953CBCS00955CBCS00959CBCS00960CBCS00961CBCS00962CBCS00966CBCS00984CBCS00985CBCS01055CBCS01059CBCS01073CBCS01074CBCS01075CBCS01076CBCS01077CBCS01078CBCS01103CBCS01109CBCS01110CBCS01111CBCS01112CBCS01113CBCS01114CBCS01115CBCS01116CBCS01117CBCS01118CBCS01119CBCS01120CBCS01125CBCS01126CBCS01127CBCS01129CBCS01130CBCS01233CBCS01236CBCS01252CBCS01253CBCS01254CBCS01069CBCS01101CBCS01102CBCS01121CBCS011225327572
- 1 5326361 - 2CBCS01049CBCS01051CBCS01060CBCS01084CBCS01104CBCS01105CBCS01106CBCS01107CBCS011085326361
- Mfg Lot or Serial #
- Amount recalled
- 911 (252 US, 659 OUS)
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Stop using this product now
GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstr¿m ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions wh
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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