BEUDAMED
    FDA Enforcement Class II Ongoing

    FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929

    Recall: Z-0367-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0367-2023
    Event ID
    90995
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Full Vision Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2022
    Initiation Date
    August 31, 2022
    Classification Date
    December 2, 2022
    Address
    3017 Full Vision Dr, N/A, Newton, KS, 67114-9750, United States

    Description

    FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929

    Reason

    This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as during a fall, the treadmill may fail to stop.

    Code Info

    UDI/DI 00860176000637, Serial Numbers: FVDC-7641, FVDC-7642, FVDC-7643

    Distribution

    Wi, GA, NY, Mexico

    Quantity

    3 units