The Recall Desk
HighFDA (Devices)·Z-0009-2014·Announced 2013-10-23

GE Healthcare Recalls Anesthesia Devices Due to Tidal Volume Overdelivery Risk

GE Healthcare is recalling specific anesthesia devices because they may deliver excessive tidal volume in a specific ventilation mode, posing a risk of harm to patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for patient harm (excessive tidal volume) but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling approximately 10,263 units of Aisys, Amingo, Avance, and Avance CS2 anesthesia devices. These devices are intended for volume or pressure control ventilation. The recall affects units distributed in the United States and in numerous countries worldwide.

The recall is due to a potential safety issue where the devices may produce an over-delivery of tidal volume. This malfunction can occur when the device is operating in Pressure Control Ventilation - Volume Guarantee (PCV-VG) mode and is subjected to a unique sequence of user inputs combined with a collapsed bellows (partially filled circuit). Exposure to excessive tidal volume can result in patient harm.

Healthcare facilities and users should identify affected units by checking the manufacturing lot or serial numbers listed in the official recall notice. Users should contact GE Healthcare for instructions on how to manage the affected devices and ensure patient safety.

The recalled product

Product
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia Machine
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Related recalls

Same manufacturer · GE Healthcare, LLC

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