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
FDA Recall Z-2617-2014 · Posted 2014-09-09
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeCCL
Date Initiated2014-08-08
Date Terminated2015-09-08
Product Quantity748 (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.
Firm Action
Consignees were sent on 8/8/2014 a GE Healthcare "Urgent Medical Device Correction" letter Ref# 36106 dated August 8, 2014. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions you can contact Technical Support at 1-800-558-7044 or your local Service Representative.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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