—#90650

Product

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

FDA product code: BSZ — Gas-Machine, Anesthesia
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K090233
Affected lot / code info: Serial Numbers: ANAN00814, ANAN00815, ANAN00825, ANAN00830, ANAN00831, ANAN00831, ANAN00832, ANAN00833, ANAN00834, ANAN00835, ANAN00836, ANAN00837, ANAN00838, ANAN00839, ANAN00873

Why it was recalled

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 (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Ge Healthcare, Llc
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide distribution: USA (CA, FL, TN), CANADA, DENMARK, FINLAND, FRANCE, ITALY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, UNITED ARAB EMIRATES, and UNITED KINGDOM.

Timeline

Recall initiated: 2010-03-12
Posted by FDA: 2010-05-11
Terminated: 2012-01-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90650. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.