BEUDAMED
    FDA Enforcement Class III Terminated

    TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.

    Recall: Z-0607-2020 · Reported December 11, 2019

    Enforcement

    Recall Number
    Z-0607-2020
    Event ID
    84168
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Theralase Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 11, 2019
    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, Power Pack component TLC-2002 Used for the temporary relief of knee pain.

    Reason

    Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.

    Code Info

    Serial Numbers on TLC-2002 Power Pack with CE Mark without CE approval: 3012 to 3204, inclusive; and 3202 to 3350 inclusive. Serial Number 3204 was sold abroad

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, WI and countries of AU, BH, CA, HK, JO, MX, PK, PH.

    Quantity

    306 units