GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.

FDA device recall Z-0009-2014 · posted 2013-10-15 · Terminated

Recall details

Recalling firm: GE Healthcare, LLC
Reason for recall: GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv
Action taken: Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated September 17, 2013. The letter was addressed to Chief of Anesthesia, Health Care Administrator / Risk Manager, and Director of Biomedical / Clinical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US call 1 800-345-2700, for other countries contact your local GE Healthcare Service Representative).
Root cause: Software design
Status: Terminated
Product code: BSZ
Quantity affected: 10,263 (3,194 US, 7,069 OUS)
Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico except DE, ME, NM, RI, and VT, and the countries of UNITED ARAB EMIRATES, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATV
Date initiated: 2013-09-16
Date posted: 2013-10-15
Date terminated: 2015-10-01
Location: Waukesha, WI

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