BEUDAMED
    FDA Enforcement Class III 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 · Reported August 28, 2019

    Enforcement

    Recall Number
    Z-2291-2019
    Event ID
    83387
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cincinnati Sub-Zero Products LLC, a Gentherm Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2019
    Initiation Date
    July 19, 2019
    Classification Date
    August 19, 2019
    Termination Date
    May 13, 2020
    Address
    12011 Mosteller Rd, N/A, Cincinnati, OH, 45241-1528, United States

    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

    Code Info

    Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165

    Distribution

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

    Quantity

    2079 units