BEUDAMED
    FDA Recall Terminated

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    Recall: Z-0845-2014 · Initiated January 13, 2014

    Recall

    Recall Number
    Z-0845-2014
    Event Number
    67319
    Firm
    Philips Healthcare
    FEI Number
    3003888399
    Product Code
    NCX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 13, 2014
    Posted
    January 27, 2014
    Terminated
    February 13, 2014
    Address
    6740 Top Gun St, San Diego, CA, 92121-4114

    Description

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    Reason

    Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.

    Action

    Philips Healthcare Recall Notice for this proactive performance correction was provided verbally to hospital biomedical engineers. Philips product support engineering scheduled and conducted the update on customer devices to the most current MCB configuration.

    Distribution

    Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland.

    Quantity

    50