Recall Z-1526-2010 ยท BSZ Gas-Machine, Anesthesia
Ge Healthcare, Llc
GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor
| Date | May 11, 2010 (initiated Mar 12, 2010) |
| Status | Terminated |
| Reason | Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring. |
| Root cause | Process design |
| Action | Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. |
| Quantity | 15 (OUS) |
| Distribution | Worldwide distribution: USA (CA, FL, TN), CANADA, DENMARK, FINLAND, FRANCE, ITALY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, UNITED ARAB EMIRATES, and UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090233 | GE DATEX-OHMEDA AISYS Datex-Ohmeda, Inc., Mar 5, 2009 |