BEUDAMED
    FDA Enforcement Class II Terminated

    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.

    Recall: Z-2057-2017 · Reported May 17, 2017

    Enforcement

    Recall Number
    Z-2057-2017
    Event ID
    76622
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Med-Hot Thermal Imaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 17, 2017
    Initiation Date
    January 14, 2017
    Classification Date
    May 9, 2017
    Termination Date
    August 7, 2019
    Address
    5120 S Florida Ave Ste 301, N/A, Lakeland, FL, 33813-2527, United States

    Description

    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.

    Reason

    Indications for use are not cleared or approved for market in the U.S.

    Code Info

    P/N 18001-EBT-MP-D with FLIR A315 camera P/N 15102-EBT-MP-D wjth FLIR A615 camera TotalVision Software versions 1.6  1.7.1

    Distribution

    US: AL and NJ - Foreign: Nigeria

    Quantity

    12