BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-2617-2014 · Initiated August 8, 2014

    Recall

    Recall Number
    Z-2617-2014
    Event Number
    68877
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    CCL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 8, 2014
    Posted
    September 9, 2014
    Terminated
    September 8, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    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

    Reason

    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.

    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.

    Distribution

    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.

    Quantity

    748 (307 units US, 441 units OUS)