BEUDAMED
    FDA Enforcement Class II 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 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0845-2014
    Event ID
    67319
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    February 5, 2014
    Initiation Date
    January 13, 2014
    Classification Date
    January 27, 2014
    Termination Date
    February 13, 2014
    Address
    6740 Top Gun St, San Diego, CA, 92121-4114, United States

    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.

    Code Info

    Model Numbers: 861470 (120V), 861472 (240V).

    Distribution

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

    Quantity

    50