BEUDAMED
    FDA Enforcement Class III Terminated

    TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.

    Recall: Z-1326-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1326-2020
    Event ID
    84845
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Theralase Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 26, 2020
    Initiation Date
    September 26, 2019
    Classification Date
    February 19, 2020
    Termination Date
    December 3, 2020
    Address
    41 Hollinger Rd, East York, N/A, Canada

    Description

    TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.

    Reason

    Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)

    Code Info

    Serial Numbers: 3275 to 3350 (inclusive)

    Distribution

    Worldwide distribution - US Nationwide and countries Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania.

    Quantity

    76 units