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GE Healthcare, LLC recalls CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and re
Recalled September 17, 2014 · FDA recall Z-2617-2014 · GE Healthcare
Hazard
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. · FDA Class II
Units
748 (307 units US, 441 units OUS)
Sold at
US: CA, CO, FL, GA, IN, KY, LA, MD,MI, NY,NC,OH, PA, SC, TN, TX, VA,WI. OUS: UNITED KINGDOM, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, PHILIPPINES, PANAMA, PAKISTAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLANDS, MEXICO, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COLOMBIA, CHILE, BULGARIA, BELGIUM, AZERBAIJAN, AUSTRALIA.
Description
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.
Product
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
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →