BEUDAMED
    FDA Enforcement Class III Terminated

    TLC-2000 Therapeutic Medical Laser System

    Recall: Z-1266-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1266-2020
    Event ID
    84846
    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 18, 2020
    Termination Date
    December 3, 2020
    Address
    41 Hollinger Rd, East York, N/A, 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

    Code Info

    Serial Numbers: 3333 to 3350 (inclusive)

    Distribution

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

    Quantity

    18 units