BEUDAMED
    FDA Enforcement Class II 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 · Reported February 25, 2015

    Enforcement

    Recall Number
    Z-1116-2015
    Event ID
    70492
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 25, 2015
    Initiation Date
    February 6, 2015
    Classification Date
    February 13, 2015
    Termination Date
    October 17, 2016
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586, United States

    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.

    Code Info

    HX2 Temperature Management System, 120V Catalog # 809810 serial numbers: 00016, 0001  1116 HX2 Temperature Management System, 100V Catalog # 812231 serial numbers: 0001, 1002, PT0003, PT0004 HX2 Temperature Management System, 240V Catalog # 812240 serial numbers: 0001, 0002 HX2 Temperature Management System, Trial Kit Catalog # 809810TK serial numbers: 1001  1042

    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