{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Waukesha", "state": "WI", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "68877", "recalling_firm": "GE Healthcare, LLC", "address_1": "3000 N Grandview Blvd", "address_2": "N/A", "postal_code": "53188-1615", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "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.", "recall_number": "Z-2617-2014", "product_description": "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", "product_quantity": "748 (307 units US, 441 units OUS)", "reason_for_recall": "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.", "recall_initiation_date": "20140808", "center_classification_date": "20140909", "termination_date": "20150908", "report_date": "20140917", "code_info": "Mfg Lot or Serial # System ID SGV14019647HA M1199109 SGV14127799HA M1199109 SGV14138150HA M1198397 SGV14148747HA M1199109 SGV14148788HA M1199049 SGV14150001HA M1199109 SGV14150005HA M1199109 SGV14150007HA M1199109 SGV14150037HA 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SGV14181898HA M1217240 SGV14192732HA M1184207 SGV14150073HA 2067388-001 SGV14150191HA 2067388-001 SGV14150192HA 2067388-001 SGV14159704HA 2067388-001 SGV14159985HA 2067388-001 SGV14159991HA 2067388-001 SGV14170899HA 2070619-001 SGV14170905HA 2070619-001 SGV14170915HA 2070619-001 SGV14192252HA 2070619-001 SGV14192259HA 2070619-001 SGV14192260HA 2070619-001 SGV14192261HA 2070619-001 SGV14192262HA 2070619-001 SGV14224431HA 2067388-001 SGV14224443HA 2067388-001 SGV14224447HA 2067388-001 SGV14224453HA 2067388-001 SGV14224461HA 2067388-001 SGV14224475HA 2067388-001 SGV14160541HA M1184207 SGV14181647HA M1184206 SGV14192741HA M1184207 SGV14192742HA M1184207 SGV14192761HA M1184207 SGV14193005HA M1184207 SGV14224436HA M1184207 SGV14224437HA M1184207 SGV14224438HA M1184207 SGV14224439HA M1184207 SGV14224466HA M1184207 SGV14224473HA M1184207 SGV14224476HA M1184207 SGV14160350HA M1226039 SGV14203396HA M1184844 SGV14203397HA M1184844 SGV14203398HA M1184844 SGV14203403HA M1184844 SGV14203406HA M1184844 SGV14203407HA M1184844 SGV14203411HA M1184844 SGV14203412HA M1184844 SGV14203414HA M1184844 SGV14160256HA 2070616-001 SGV14171153HA 2070616-001 SGV14182022HA 2065638-001 SGV14192247HA 2070616-001 SGV14192248HA 2070616-001 SGV14192249HA 2070616-001 SGV14192251HA 2070616-001 SGV14192253HA 2070616-001 SGV14192254HA 2070616-001 SGV14192256HA 2070616-001 SGV14192257HA 2070616-001 SGV14159967HA 2065628-001 SGV14150176HA M1184207 SGV14159975HA M1184207 SGV14148744HA M1179136-X SGV14150040HA M1184207 SGV14150046HA M1179136-X SGV14150048HA M1179136-X SGV14150058HA M1179136-X SGV14150036HA M1184207 SGV14150038HA M1184207 SGV14150061HA M1184207 SGV14159403HA M1217240 SGV14159478HA M1184207 SGV14159500HA M1184207 SGV14159690HA M1184207 SGV14159696HA M1184207 SGV14159701HA M1184207 SGV14159974HA M1184207 SGV14159980HA M1184207 SGV14159992HA M1184207 SGV14159996HA M1184207 SGV14159998HA M1184207 SGV14160343HA M1217240 SGV14160518HA M1184207 SGV14181892HA M1217240 SGV14181893HA M1217240 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SGV14170927HA M1226032 SGV14170928HA M1226032 SGV14171160HA M1226032 SGV14224434HA M1184207 SGV14224472HA M1184207 SGV14181852HA 2065605-001 SGV14224440HA 2067394-001 SGV14224459HA 2067394-001 SGV14150053HA 2065628-001 SGV14150057HA M1184207 SGV14150078HA M1184207 SGV14150190HA M1184207 SGV14160327HA M1184207 SGV14192282HA M1217240 SGV14182006HA 2067395-001 SGV14192762HA 2067395-001 SGV14192994HA 2067395-001 SGV14193002HA 2067395-001 SGV14193003HA 2067395-001 SGV14224451HA 2067395-001 SGV14224478HA 2067395-001 SGV14224460HA M1184207 SGV14224470HA M1184207 SGV14150002HA 2065633-001 SGV14150174HA 2065633-001 SGV14159705HA 2065633-001 SGV14160246HA 2070611-001 SGV14160251HA 2070611-001 SGV14160253HA 2070611-001 SGV14170900HA 2070611-001 SGV14224467HA 2065633-001 SGV14150171HA 2065632-001 SGV14150186HA 2065632-001 SGV14150198HA 2065632-001 SGV14159710HA 2065632-001 SGV14170914HA 2070610-001 SGV14192731HA 2065632-001 SGV14192738HA M1184207 SGV14192977HA M1184207 SGV14149258HA M1184207 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2070608-001 SGV14171149HA 2070608-001 SGV14171151HA 2070608-001 SGV14171152HA 2070608-001 SGV14171154HA 2070608-001 SGV14171158HA 2070608-001 SGV14171159HA 2070608-001 SGV14171161HA 2070608-001 SGV14192263HA 2070608-001 SGV14224462HA 2065630-001 SGV14150072HA 2073871-001 SGV14159977HA SGV14160328HA SGV14160516HA SGV14170925HA SGV14192615HA 2065600-001 SGV14192617HA 2065600-001 SGV14192618HA 2065600-001 SGV14192758HA 2065629-001 SGV14203027HA SGV14203256HA SGV14203282HA SGV14203285HA SGV14203288HA SGV14203289HA SGV14203294HA SGV14203379HA SGV14203392HA SGV14203658HA SGV14203661HA 2073871-001 SGV14213834HA SGV14213854HA SGV14214087HA SGV14214114HA 2073871-001 SGV14235437HA SGV14150185HA M1184207 SGV14150193HA M1184207 SGV14160536HA M1184207 SGV14160538HA M1184207 SGV14160547HA M1184207 SGV14192722HA M1184207 SGV14192760HA M1184207 SGV14224444HA M1184207 SGV14224450HA M1184207 SGV14224454HA M1184207 SGV14224464HA M1184207 SGV14224468HA M1184207 SGV14224469HA M1184207 SGV14224477HA M1184207 SGV14224479HA M1184207 SGV14150006HA 2065622-001 SGV14159398HA M1184672 SGV14160329HA M1184672 SGV14160330HA M1184672 SGV14160331HA M1184672 SGV14160332HA M1184672 SGV14160333HA M1184672 SGV14181887HA M1184672 SGV14181891HA M1184672 SGV14192267HA M1184672 SGV14192269HA M1184672 SGV14192273HA M1184672 SGV14192274HA M1184672 SGV14193006HA 2065622-001 SGV14159706HA 2065628-001 SGV14159984HA 2065628-001 SGV14150067HA 2065628-001 SGV14150189HA 2065628-001 SGV14150201HA 2065628-001 SGV14159715HA 2065628-001 SGV14160323HA 2065628-001 SGV14160542HA 2065628-001 SGV14150056HA 2067396-001 SGV14150165HA 2067396-001 SGV14150169HA 2067396-001 SGV14150184HA 2067396-001 SGV14150205HA 2067396-001 SGV14150206HA 2067396-001 SGV14159982HA 2067396-001 SGV14160231HA 2070612-001 SGV14160239HA 2070612-001 SGV14170901HA 2070612-001 SGV14170908HA 2070612-001 SGV14192245HA 2070612-001 SGV14192255HA 2070612-001 SGV14192264HA 2070612-001 SGV14192728HA 2065634-001 SGV14160540HA 2065639-001 SGV14160544HA 2065639-001 SGV14150000HA M1184207 SGV14150054HA M1184207 SGV14150059HA M1184207 SGV14150062HA M1184207 SGV14150069HA M1184207 SGV14150070HA M1184207 SGV14159475HA M1184207 SGV14160224HA M1226032 SGV14160229HA M1226032 SGV14160238HA M1226032 SGV14160242HA M1226032 SGV14160243HA M1226032 SGV14160250HA M1226032 SGV14160252HA M1226032 SGV14160257HA M1226032 SGV14160259HA M1226032 SGV14170910HA M1226032 SGV14170913HA M1226032 SGV14170929HA M1226032 SGV14170933HA M1226032 SGV14170935HA M1226032 SGV14170937HA M1226032 SGV14171145HA M1226032 SGV14171148HA M1226032 SGV14171155HA M1226032 SGV14171156HA M1226032 SGV14171157HA M1226032 SGV14171164HA M1226032 SGV14171165HA M1226032 SGV14171166HA M1226032 SGV14171167HA M1226032 SGV14171168HA M1226032 SGV14171169HA M1226032 SGV14171170HA M1226032 SGV14171171HA M1226032 SGV14171172HA M1226032 SGV14171174HA M1226032 SGV14171175HA M1226032 SGV14171176HA M1226032 SGV14171177HA M1226032 SGV14171179HA M1226032 SGV14171180HA M1226032 SGV14171181HA M1226032 SGV14171182HA M1226032 SGV14171183HA M1226032 SGV14171184HA M1226032 SGV14171185HA M1226032 SGV14171186HA M1226032 SGV14171187HA M1226032 SGV14171188HA M1226032 SGV14181435HA M1184206 SGV14181437HA M1184206 SGV14181438HA M1184206 SGV14181439HA M1184206 SGV14181440HA M1184206 SGV14181445HA M1184206 SGV14181446HA M1184206 SGV14181448HA M1184206 SGV14181450HA M1184206 SGV14181454HA M1184206 SGV14181455HA M1184206 SGV14181456HA M1184206 SGV14181617HA M1184206 SGV14181619HA M1184206 SGV14181620HA M1184206 SGV14181623HA M1184206 SGV14181625HA M1184206 SGV14181627HA M1184206 SGV14181629HA M1184206 SGV14181632HA M1184206 SGV14181634HA M1184206 SGV14181636HA M1184206 SGV14181637HA M1184206 SGV14181638HA M1184206 SGV14181639HA M1184206 SGV14181645HA M1184206 SGV14181646HA M1184206 SGV14181855HA M1184206 SGV14181858HA M1184206 SGV14181861HA M1184206 SGV14181862HA M1184206 SGV14181863HA M1184206 SGV14181864HA M1184206 SGV14181865HA M1184206 SGV14181866HA M1184206 SGV14181867HA M1184206 SGV14181868HA M1184206 SGV14181869HA M1184206 SGV14181870HA M1184206 SGV14181871HA M1184206 SGV14181874HA M1184206 SGV14181875HA M1184206 SGV14181876HA M1184206 SGV14192246HA M1226032 SGV14192258HA M1226032 SGV14192265HA M1184671 SGV14192268HA M1184671 SGV14192270HA M1184671 SGV14192748HA M1184207 SGV14203286HA M1184206 SGV14203287HA M1184206 SGV14203291HA M1184206 SGV14203293HA M1184206 SGV14224471HA M1184207" } ] }