The Recall Desk
ModerateFDA (Devices)·Z-0010-2014·Announced 2013-10-23

GE Healthcare Recalls Ventilators and Anesthesia Machines with Unresponsive Buttons

GE Healthcare is recalling 911 ventilators and anesthesia machines because manufacturing defects may cause display buttons to fail, preventing access to menu functions.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences, and the source text does not report any injuries or illnesses.

Plain-English summary

GE Healthcare, LLC is recalling 911 units of the Avance, Avance CS2, Aisys, Aespire View, and Engstrom ventilators and anesthesia machines. These devices are intended for volume or pressure control ventilation. The recall affects 252 units in the United States and 659 units outside the US.

The recall is due to a manufacturing issue that may cause buttons on the left, right, and bottom keypads to fail to detect presses. This defect may result in the inability to access certain menu functions on the device display.

The affected units were distributed worldwide, including nationwide in the United States and in numerous countries across Europe, Asia, the Americas, and Africa. Users should contact GE Healthcare for instructions on how to address the issue.

The recalled product

Product
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
Manufacturer
GE Healthcare, LLC

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically: