GE Aisys Anesthesia System Recalled for Potential Barotrauma Risk
GE Medical Systems is recalling 13 Aisys Anesthesia Systems because a stuck valve could cause excessive pressure in the patient breathing circuit, potentially resulting in barotrauma.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II and involves a medical device defect that could result in barotrauma, a significant injury to the lungs, meeting the criteria for a Severe rating.
Plain-English summary
GE Medical Systems, LLC is recalling 13 units of the GE Datex-Ohmeda Aisys Anesthesia System (model 1011-9000-000). The device is 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.
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. If left unresolved, the issue could result in excessive or prolonged pressure in the patient breathing circuit during ventilation, potentially leading to barotrauma.
Healthcare facilities should contact GE Medical Systems to verify if their specific serial numbers are affected and follow the company's instructions for repair or replacement. The affected serial numbers are listed in the agency's recall record.
The recalled product
- Product
- GE Healthcare, Aisys, 1011-9000-000. 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). The device is intended for volume or pressure control…
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 13
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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