PlainRecordsFDA · Medical device recall
GE… and 1 more product
- Date posted by the FDA
- May 11, 2010
- Status
- Terminated
- Filed by
- Ge Healthcare, Llc
- 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.
- Distribution pattern
- Worldwide distribution: USA (CA, FL, TN), CANADA, DENMARK, FINLAND, FRANCE, ITALY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
2 products in this recall
GE…
- Product
- GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor
- Quantity
- 15 (OUS)
- Codes and lots
- Serial Numbers: ANAN00814, ANAN00815, ANAN00825, ANAN00830, ANAN00831, ANAN00831, ANAN00832, ANAN00833, ANAN00834, ANAN00835, ANAN00836, ANAN00837, ANAN00838, ANAN00839, ANAN00873
- Recall started
- March 12, 2010
- Device type
- Gas-Machine, Anesthesia
- Root cause (FDA)
- Process design
- What the company told customers
- 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.
- Recall number
- Z-1526-2010
GE…
- Product
- GE, 1009-9002-000 Avance Anesthesia Machine and Monitor
- Quantity
- 18 (4 USA, 14 OUS)
- Codes and lots
- Serial Numbers: ANBN01180, ANBN01187, ANBN01200, ANBN01201, ANBN01211, ANBN01212, ANBN01213, ANBN01220, ANBN01223, ANBN01224, ANBN01250, ANBN01266, ANBN01284, ANBN01285, ANBN01286, ANBN01287, ANBN01288, ANBN01289
- Recall started
- March 12, 2010
- Device type
- Gas-Machine, Anesthesia
- Root cause (FDA)
- Process design
- What the company told customers
- 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.
- Recall number
- Z-1527-2010
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1526-2010, Z-1527-2010. The agency record governs; check it and the company before acting.