BEUDAMED
    FDA Enforcement Class III Terminated

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

    Recall: Z-1348-2020 · Reported March 4, 2020

    Enforcement

    Recall Number
    Z-1348-2020
    Event ID
    84842
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Theralase Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 4, 2020
    Initiation Date
    September 26, 2019
    Classification Date
    February 24, 2020
    Termination Date
    December 3, 2020
    Address
    41 Hollinger Rd, N/A, East York, N/A, N/A, 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

    Code Info

    Serial Numbers: 3104-3106 (inclusive); 3109 to 3141 (inclusive), 3143, 3146, 3147, 3155, 3158, 3159, 3163-3165 (inclusive), 3168-3173 (inclusive), 3180-3184 (inclusive), 3188-3332 (inclusive), 3334

    Distribution

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

    Quantity

    202 units