BEUDAMED
    FDA Recall Terminated

    TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002

    Recall: Z-1348-2020 · Initiated September 26, 2019

    Recall

    Recall Number
    Z-1348-2020
    Event Number
    84842
    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 Power Pack, Model Number TLC-2002

    Reason

    Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards

    Action

    Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Please courier your TLC-2000 to Theralase, at your cost, for modification. A Field Inspection Test will be completed and once passed, a Special Inspections for Medical Electrical Equipment and Systems label will be applied to your TLC-2000 Power Pack..

    Distribution

    U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

    Quantity

    202 units