BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1326-2020 · Initiated September 26, 2019

    Recall

    Recall Number
    Z-1326-2020
    Event Number
    84845
    Firm
    Theralase Inc.
    FEI Number
    3003614490
    Product Code
    NHN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 26, 2019
    Posted
    February 13, 2020
    Terminated
    December 3, 2020
    Address
    41 Hollinger Rd, East York 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)

    Action

    Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Healthcare practitioners are instructed to courier their TLC-2000 to Theralase. A Field Inspection Test will be completed and once passed, a Special Inspections for Medical Electrical Equipment and Systems label will be applied to the TLC-2000.The Field Inspection Test will be completed according to either CSA 60601-1 or UL 60601-1 dependent upon the customers Canadian or United States location, respectively.

    Distribution

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

    Quantity

    76 units