BEUDAMED
    FDA Enforcement Class II Ongoing

    TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928

    Recall: Z-2054-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2054-2023
    Event ID
    92382
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Full Vision Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2023
    Initiation Date
    May 12, 2023
    Classification Date
    June 30, 2023
    Address
    3017 Full Vision Dr, N/A, Newton, KS, 67114-9750, United States

    Description

    TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928

    Reason

    Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

    Code Info

    UDI/DI 00860176000620, Serial Numbers: FVDC-7644, FVDC-7645, FVDC-7646, FVDC-7686, FVDC-7786, FVDC-7888, FVDC-7927, FVDC-8192, FVDC-8255, FVDC-8310, FVDC-8316, FVDC-8317, FVDC-8318, FVDC-8319, FVDC-8320, FVDC-8321, FVDC-8322, FVDC-8323, FVDC-8324, FVDC-8325, FVDC-8386, FVDC-8387, FVDC-8416, FVDC-8542, FVDC-8543, FVDC-8544, FVDC-8545, FVDC-8546, FVDC-8547, FVDC-8617, FVDC-8618, FVDC-8731, FVDC-8802, FVDC-8809, FVDC-8810, FVDC-8812, FVDC-8813, FVDC-8815, FVDC-8816

    Distribution

    USA (Nationwide), Australia, Bahrain, Canada, Chile, Colombia, Costa Rica, Dominican Republic, FINLAND, Guatemala, HONG KONG, India, Indonesia, Israel, Mexico, NEW ZEALAND, Nicaragua, Panama, PARAQUAY, Peru, Philippines, Saudi Arabia, Singapore, SOUTH KOREA, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uruguay

    Quantity

    39 units