BEUDAMED
    FDA Recall Terminated

    MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.

    Recall: Z-2291-2019 · Initiated July 19, 2019

    Recall

    Recall Number
    Z-2291-2019
    Event Number
    83387
    Firm
    Cincinnati Sub-Zero Products LLC, a Gentherm Company
    FEI Number
    1516825
    Product Code
    ILO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 19, 2019
    Terminated
    May 13, 2020
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241-1528

    Description

    MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.

    Reason

    Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage

    Action

    Gentherm issued an Urgent Medical Device Notification on 7/19/19 via UPS informing users of the problem, health risk and action to take :Immediately examine your inventory and update manual(s) subject to recall and ensure that obsolete manuals are removed from service In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. INSTRUCTIONS TO CUSTOMERS: 1) Access updated manuals and ensure that obsolete manuals are removed from service. Updated manuals maybe accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at 1-888-437-0608.

    Distribution

    Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES

    Quantity

    2079 units