FDAFDA · Food and drugs·Recall number Z-2617-2014
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
Published September 17, 2014 · Recall initiated: August 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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.
- Lot
- Mfg Lot or Serial # System ID SGV14019647HA M1199109 SGV14127799HA M1199109 SGV14138150HA M1198397 SGV14148747HA M1199109 SGV14148788HA M1199049 SGV14150001HA M1199109 SGV14150005HA M1199109 SGV14150007HA M1199109 SGV14150037HA M1199109 SGV14150039HA M1199109 SGV14150041HA M1199109 SGV14150042HA M1199109 SGV14150043HA M1199109 SGV14150044HA M1199109 SGV14150045HA M1199109 SGV14150051HA M1199109 SGV14150060HA M1199109 SGV14150064HA M1199109 SGV14150068HA M1199109 SGV14150071HA M1199109 SGV14150074HA M1199109 SGV14150075HA M1199109 SGV14150079HA M1199109 SGV14150170HA M1199109 SGV14150179HA M1199109 SGV14150180HA M1199109 SGV14150182HA M1199109 SGV14150194HA M1199109 SGV14150195HA M1199109 SGV14150197HA M1199109 SGV14150203HA M1199109 SGV14150204HA M1199109 SGV14150207HA M1199109 SGV14150208HA M1199109 SGV14159469HA M1199109 SGV14159471HA M1199109 SGV14159472HA M1199109 SGV14159484HA M1199109 SGV14159488HA M1199109 SGV14159489HA M1199109 SGV14159490HA M1199109 SGV14159494HA M1199109 SGV14159498HA M1199109 SGV14159499HA M1199109 SGV14159501HA M1199109 SGV14159502HA M1199109 SGV14159504HA M1199109 SGV14159505HA M1199109 SGV14159506HA M1199109 SGV14159507HA M1199109 SGV14159685HA M1199109 SGV14159688HA M1199109 SGV14159689HA M1199109 SGV14159692HA M1199109 SGV14159694HA M1199109 SGV14159695HA M1199109 SGV14159698HA M1199109 SGV14159703HA M1199109 SGV14159707HA M1199109 SGV14159709HA M1199109 SGV14159713HA M1199109 SGV14159716HA M1199109 SGV14159717HA M1199109 SGV14159718HA M1199109 SGV14159722HA M1199109 SGV14159728HA M1199109 SGV14159966HA M1199109 SGV14159971HA M1199109 SGV14159976HA M1199109 SGV14159978HA M1199109 SGV14159979HA M1199109 SGV14159990HA M1199109 SGV14159995HA M1199109 SGV14159999HA M1199109 SGV14160322HA M1199109 SGV14160324HA M1199109 SGV14160325HA M1199109 SGV14160511HA M1199109 SGV14160512HA M1199109 SGV14160513HA M1199109 SGV14160514HA M1199109 SGV14160515HA M1199109 SGV14160519HA M1199109 SGV14160520HA M1199109 SGV14160522HA M1199109 SGV14160524HA M1199109 SGV14160525HA M1199109 SGV14160526HA M1199109 SGV14160529HA M1199109 SGV14160532HA M1199109 SGV14160534HA M1199109 SGV14160539HA M1199109 SGV14160545HA M1199109 SGV14181423HA M1199049 SGV14181424HA M1199049 SGV14181425HA M1199049 SGV14181426HA M1199049 SGV14181427HA M1199049 SGV14181428HA M1199049 SGV14181429HA M1199049 SGV14181430HA M1199049 SGV14181432HA M1199049 SGV14181433HA M1199049 SGV14181434HA M1199049 SGV14181436HA M1199049 SGV14181441HA M1199049 SGV14181442HA M1199049 SGV14181447HA M1199049 SGV14181451HA M1199049 SGV14181452HA M1199049 SGV14181453HA M1199049 SGV14181457HA M1199049 SGV14181458HA M1199049 SGV14181459HA M1199049 SGV14181460HA M1199049 SGV14181461HA M1199049 SGV14181609HA M1199049 SGV14181610HA M1199049 SGV14181611HA M1199049 SGV14181612HA M1199049 SGV14181613HA M1199049 SGV14181614HA M1199049 SGV14181615HA M1199049 SGV14181616HA M1199049 SGV14181618HA M1199049 SGV14181621HA M1199049 SGV14181622HA M1199049 SGV14181624HA M1199049 SGV14181628HA M1199049 SGV14181630HA M1199049 SGV14181631HA M1199049 SGV14181633HA M1199049 SGV14181635HA M1199049 SGV14181641HA M1199049 SGV14181642HA M1199049 SGV14181643HA M1199049 SGV14181648HA M1199049 SGV14181853HA M1199049 SGV14181854HA M1199049 SGV14181856HA M1199049 SGV14181859HA M1199049 SGV14181860HA M1199049 SGV14181997HA M1199109 SGV14181999HA M1199109 SGV14182000HA M1199109 SGV14182001HA M1199109 SGV14182003HA M1199109 SGV14182005HA M1199109 SGV14182007HA M1199109 SGV14182008HA M1199109 SGV14182009HA M1199109 SGV14182010HA M1199109 SGV14182011HA M1199109 SGV14182012HA M1199109 SGV14182015HA M1199109 SGV14192266HA M1198396 SGV14192272HA M1198396 SGV14192612HA M1199049 SGV14192613HA M1199049 SGV14192614HA M1199049 SGV14192616HA M1199049 SGV14192619HA M1199049 SGV14192621HA M1199049 SGV14192622HA M1199049 SGV14192623HA M1199049 SGV141926
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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