Recall Z-0755-2017 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare, LLC
GE Healthcare, Avance, Avance CS2, Amingo.
| Date | Nov 3, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 23,098 (US = 8,711; OUS = 14,387) |
| Distribution | 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 |
| FDA record | Open on fda.gov |