Amingo, Avance, Avance CS2 Class I GE Aisys

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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