GE Healthcare Anesthesia Systems Recalled for Potential Barotrauma Risk
GE Medical Systems is recalling certain Aisys and Avance anesthesia systems because a stuck valve could cause excessive pressure in the patient breathing circuit, potentially leading to barotrauma.
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 is classified as FDA Class II and involves a risk of serious injury (barotrauma) from a medical device defect, but no reported illnesses or injuries are stated in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Medical Systems, LLC is recalling 2,627 units of GE Healthcare Aisys CS2, Avance Amingo, and Avance CS2 anesthesia systems. The recall is due to a defect in the Drive Gas Check Valve, which could become stuck in a fixed open position.
If the valve remains stuck open, pressure could build up during the mechanical ventilation cycle. This could result in excessive or prolonged pressure in the patient breathing circuit, potentially causing barotrauma to the patient.
The affected devices are intended to provide general inhalation anesthesia and ventilatory support to neonatal, pediatric, and adult patients. The recall covers units distributed worldwide, including the United States (excluding New Hampshire, Vermont, and Wyoming) and numerous international locations. Healthcare facilities should contact GE Medical Systems for instructions on how to address the defect.
The recalled product
- Product
- GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). T
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 2,627
Distribution
Part of a larger recall action
This product is one of 6 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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