FDA Medical Device Recalls (openFDA)
Ge Healthcare, Llc: GE, 1009-9002-000 Avance Anesthesia Machine and Monitor
- Recall number
- Z-1527-2010
- Recalling firm
- Ge Healthcare, Llc
- Product
- GE, 1009-9002-000 Avance Anesthesia Machine and Monitor
- Status
- Terminated
- Initiated
- 2010-03-12
- Posted
- 2010-05-11
- Terminated
- 2012-01-30
- 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
- 18 (4 USA, 14 OUS)
- Distribution
- Worldwide distribution: USA (CA, FL, TN), CANADA, DENMARK, FINLAND, FRANCE, ITALY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
- Lot, serial or model codes
- Serial Numbers: ANBN01180, ANBN01187, ANBN01200, ANBN01201, ANBN01211, ANBN01212, ANBN01213, ANBN01220, ANBN01223, ANBN01224, ANBN01250, ANBN01266, ANBN01284, ANBN01285, ANBN01286, ANBN01287, ANBN01288, ANBN01289
- 510(k) numbers
- ["K081844"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28