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.
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 the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may…"
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
Distribution
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