Reported Dec 21, 2016 · Terminated
GE Healthcare, Avance, Avance CS2, Amingo.
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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, Amingo.
- Lot codes and dates
- FMI 34079 Initial Consignee List Mfg. Lot or Serial #APKV00626`
2,809 of 2,809 codes
ANBM00775ANBM00776ANBM00779ANBN00775ANBR01060APKS01034APKT00107APKT02107APKU00169APKU00170APKU00171APKU01696APKU01697APKU01698APKU01699APKV00455APKV00456APKV00457APKV00458ANBH00259ANBP00673ANBP01851ANBP02120ANBP02121APKS01352APKS01353APKS01354APKS01355APKS01356APKT02322APKT02323APKT02324APKT02325APKT02326APKV01600APKV01601APKV01602APKV01554APKV01555APKV01556APKV01557APKV01558APKV01559APKV01560APKV01561APKV01562APKV01198APKV01199APKV01200APKV01201ANBQ01418ANBQ01419ANBQ01420ANBQ01421ANBR01342APKV00450APKV00451ANBM00230ANBM00273ANBM00497
149 of 149 codes
APKV00627APKV00628ANBN00777ANBN00778ANBQ00111ANBQ00112ANBQ00113ANBQ00164ANBQ00165ANBQ00177ANBQ00178ANBQ00179ANBQ00180ANBQ01668ANBQ01669APKV01011APKU00498APKU00499ANBQ00922APKT00986APKT00987APKT00988APKV00435APKV00436APKV00437APKV00438APKV00439APKV00440APKV00441APKV00442APKV00443APKV00444APKV00445APKV00446APKV00447APKV00448APKV01182APKV01183APKV01184APKV01185APKV01186ANBP01692ANBP01693APKS00529APKS01157APKS01158APKT03365APKT03366APKT03367APKV00402APKV00403APKV00404APKV00405APKV00406APKV00407APKV00408APKV00409APKV00410ANBG00119APKV01223
- FMI 34079 Initial Consignee List Mfg. Lot or Serial #
- Amount recalled
- 23,098 (US = 8,711; OUS = 14,387)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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