Company: GE Healthcare, LLC
Date of Enforcement Report: 10/23/2013
Class l:

PRODUCT

GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation. Recall Number Z-0009-2014

REASON
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 excessive tidal volumes while pressure limits are maintained can result in pulmonary volutrauma and/or an increased pulmonary vascular resistance that can negatively affect cardiac filling pressure and/or stroke volume.

RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 9/16/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
10,263 (3,194 US, 7,069 OUS)

DISTRIBUTION
Nationwide and Internationally

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