GE Medical Systems Recalls Anesthesia Device Service Kits Due to Valve Defect
GE Medical Systems is recalling 240 anesthesia device service kits because a drive gas check valve could become stuck open, potentially causing excessive pressure in the patient breathing circuit.
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. The hazard involves a risk of harm (barotrauma) from a mechanical defect in a medical device, but the source text does not report any specific injuries or illnesses, 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 240 anesthesia device service kits. The affected products include various ventilation engine assemblies and service kits containing the ventilator Drive Gas Check Valve, which were shipped from April 20, 2015, through October 2015. These kits could have been installed on Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2 Anesthesia, and Amingo devices.
The recall is due to a defect where the Drive Gas Check Valve could become stuck in a fixed open position. This issue could cause pressure to build in the mechanical ventilation cycle. If left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation, potentially resulting in barotrauma.
The affected units were distributed worldwide, including nationwide in the United States (excluding New Hampshire, Vermont, and Wyoming) and in numerous international markets. Healthcare providers and facilities should contact GE Medical Systems to determine if their devices are affected and to arrange for necessary service or replacement.
The recalled product
- Product
- Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 ASSY-MSN, VLV ASSY DR GAS CHK
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 240
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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