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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstr¿m ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue…"
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
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