GE Healthcare Recalls Avance and Amingo Anesthesia Devices Due to Malfunction Risk
GE Healthcare is recalling specific Avance CS2, Avance, and Amingo anesthesia devices because they may enter a System Malfunction state if a storage drawer closes with excessive force.
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 system malfunction that could impact patient safety, but no injuries or illnesses have been reported, 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 certain Avance CS2, Avance, and Amingo anesthesia devices. The recall involves 23,098 units distributed in the United States and internationally.
The recall is due to a potential safety issue where these devices can transition to a System Malfunction state if the lower storage drawer containing the optional large tray insert accessory is closed with an abnormally high amount of force. This malfunction could affect the operation of the anesthesia equipment.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. GE Healthcare is managing the recall to address this potential safety issue.
The recalled product
- Product
- GE Healthcare, Avance, Avance CS2, Amingo.
- Manufacturer
- GE Healthcare, LLC
- Hazard
Distribution
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