Reported Jan 27, 2016 · Terminated
GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general…
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, 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 ventilation. The Aisys is not suitable for use in a MRI environment.
- Lot codes and dates
ANAU00153ANAU00156ANAU00152ANAU00150ANAU00151ANAU00154ANAU00155ANAU00157ANAU00158ANAU00159ANAU00160ANAU00180ANAU00181
- Amount recalled
- 13
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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