Reported Sep 17, 2014 · Terminated
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and…
GE Healthcare, 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 Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with
- any of the following GE host devices-CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor
- Lot codes and dates
- Mfg Lot or Serial # System ID
1,478 of 1,478 codes
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
- Mfg Lot or Serial # System ID
- Amount recalled
- 748 (307 units US, 441 units OUS)
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units.
This product could cause temporary or reversible health problems — stop using it.
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