GE Healthcare Aestiva MRI Ventilator Recalled for Valve Defect
GE Medical Systems is recalling 84 Aestiva MRI anesthesia systems because a drive gas check valve may 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 involves a medical device defect that could result in barotrauma (a form of injury), but the source text does not report any actual injuries or illnesses, fitting the criteria for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
GE Medical Systems, LLC is recalling 84 units of the GE Healthcare Aestiva MRI anesthesia system, model 1006-9310-000. This device is a microprocessor-based, electronically controlled, pneumatically driven ventilator used in Datex-Ohmeda Aestiva/5 anesthesia systems to provide patient ventilation during surgical procedures in the MR environment.
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.
The affected units were distributed worldwide, including nationwide in the United States (excluding New Hampshire, Vermont, and Wyoming) and in numerous international markets. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during sur
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 84
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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