GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor
FDA device recall Z-1526-2010 · posted 2010-05-11 · Terminated
Recall details
- Recalling firm
- Ge Healthcare, Llc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 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.
- Date initiated
- 2010-03-12
- Date posted
- 2010-05-11
- Date terminated
- 2012-01-30
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE DATEX-OHMEDA AISYS (K090233) | Datex-Ohmeda, Inc. | 2009-03-05 |