Reported Oct 23, 2013 · Terminated
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
GE Healthcare, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
- Lot codes and dates
- Mfg Lot or Serial #
2,962 of 2,962 codes
ANBR01060ANAQ01557ANBQ01421ANBQ01418ANBQ01419ANBQ01420ANBR01342ANBR00292ANBR00289ANBR00293ANBR00290ANBR00291ANBR00294ANBR00295ANBQ01522ANBQ01520ANBQ01524ANBQ01521ANBQ01523ANBQ02209ANBQ02212ANBQ02213ANBQ02210ANBQ02211ANBS00535ANBR01079ANBR01078ANBR01080ANAQ00842ANBR01053ANBR01054ANBQ01015ANBQ01965ANBQ01480ANBQ01966ANBQ01484ANBS00304ANBS00305ANAR00675ANAR05794ANAR05793ANBQ01751ANBR00248ANAS00596ANAS00593ANBQ01055ANBQ01052ANBQ01056ANBQ01051ANBQ01053ANBQ01054ANAQ01176ANAQ01177ANAR05091ANAR05174ANBQ00785ANBQ00786ANBR00256ANBQ01664ANBQ01259
- Mfg Lot or Serial #
- Amount recalled
- 10,263 (3,194 US, 7,069 OUS)
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
Stop using this product now
GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv
Using this product could cause serious injury, illness or death — stop using it now.
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