GE Aespire Anesthesia Systems Recalled for Potential Barotrauma Risk
GE Medical Systems is recalling Aespire 7900 and Aespire View anesthesia systems because a stuck valve could cause excessive pressure and barotrauma.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of barotrauma (significant injury) to patients, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
GE Medical Systems, LLC is recalling 1,081 units of the GE Datex-Ohmeda Aespire 7900 and Aespire View anesthesia systems. These devices are intended to provide general inhalation anesthesia and ventilatory support to patients. The recall covers units distributed nationwide in the United States (excluding New Hampshire, Vermont, and Wyoming) and internationally to numerous countries.
The recall is due to a defect in the Drive Gas Check Valve, which could become stuck in a fixed open position. This malfunction could cause pressure to build in the mechanical ventilation cycle, resulting in excessive or prolonged pressure in the patient breathing circuit. If left unresolved, this condition could potentially result in barotrauma to the patient.
Healthcare facilities and users should contact GE Medical Systems for instructions on how to address the defect. The source text does not specify a particular action such as stopping use immediately, but the risk of barotrauma indicates a significant safety concern for patients undergoing ventilation.
The recalled product
- Product
- GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 1,081
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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