BEUDAMED
    FDA Recall Terminated

    Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.

    Recall: Z-1116-2015 · Initiated February 6, 2015

    Recall

    Recall Number
    Z-1116-2015
    Event Number
    70492
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DWC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 6, 2015
    Posted
    February 13, 2015
    Terminated
    October 17, 2016
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.

    Reason

    Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular intervals.

    Action

    On 2/6/2015, URGENT MEDICAL DEVICE RECALL notifications were mailed to the affected hospitals. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call customer service at 1-800-521-2818.

    Distribution

    US (nationwide) including the states of AR, CA, CO, CT, FL, IA, IL, KS, KY, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA, and WI and the country of Japan.

    Quantity

    103 units