Reported Jan 27, 2016 · Terminated
GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda…
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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 surgical procedures. The Aestiva/5 MRI anesthesia system provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment.
- Lot codes and dates
84 of 84 codes
AMTU01048AMTU01023AMTU00163AMTU01050AMTU00172AMTU00175AMTU00176AMTU01034AMTU01047AMTU01055AMTU01001AMTU01002AMTU01021AMTU01044AMTU01042AMTU01015AMTU00178AMTU00179AMTU00162AMTU01000AMTU01012AMTU01041AMTU00167AMTU01019AMTU00177AMTU01049AMTU00171AMTU00164AMTU01066AMTU01006AMTU00168AMTU01061AMTU01060AMTU01056AMTU01057AMTU01073AMTU00154AMTU00166AMTU00174AMTU01005AMTU01035AMTU00150AMTU01024AMTU01025AMTU01026AMTU01027AMTU01037AMTU00152AMTU01040AMTU01022AMTU00157AMTU00158AMTU00159AMTU00160AMTU00170AMTU01018AMTU01009AMTU01032AMTU01046AMTU01045
- Amount recalled
- 84
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
This product could cause temporary or reversible health problems — stop using it.
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