BEUDAMED
    FDA Recall Terminated

    TLC-2000 Therapeutic Medical Laser System

    Recall: Z-1266-2020 · Initiated September 26, 2019

    Recall

    Recall Number
    Z-1266-2020
    Event Number
    84846
    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

    Reason

    Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard

    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. The TLC-2000 will be updated to reduce EMI to meet IEC 60601-1-2 standard (4th edition).

    Distribution

    Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

    Quantity

    18 units