Z-1526-2010

GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor

Name: Z-1526-2010 GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor
Creator: Ge Healthcare, Llc
Published: 2010-03-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2010-03-12 / Terminated / root cause: manufacturing process

FDA source

Ge Healthcare, Llc began a recall of GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor on 2010-03-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1526-2010
Status: Terminated
Initiated: 2010-03-12
Posted: 2010-05-11
Terminated: 2012-01-30
Recalling firm: GE Healthcare
Product: GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor
Product code: BSZ Gas-Machine, Anesthesia
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Serial Numbers: ANAN00814, ANAN00815, ANAN00825, ANAN00830, ANAN00831, ANAN00831, ANAN00832, ANAN00833, ANAN00834, ANAN00835, ANAN00836, ANAN00837, ANAN00838, ANAN00839, ANAN00873

Product code BSZ

K090233Class IIGe Datex-Ohmeda AisysDatex-Ohmeda, Inc. / cleared 2009-03-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)