BEUDAMED
    FDA Enforcement Class II Ongoing

    ClubMax Laser Projection Series

    Recall: Z-2092-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2092-2019
    Event ID
    83438
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Gk Photonics Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    August 14, 2019
    Initiation Date
    July 10, 2019
    Classification Date
    August 7, 2019
    Address
    717 Ridge Dr, N/A, Glendale, CA, 91206-1752, United States

    Description

    ClubMax Laser Projection Series

    Reason

    The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons.

    Code Info

    ClubMax Laser Projection Series

    Distribution

    Unknown

    Quantity

    1291 total