BEUDAMED
    FDA Recall Open, Classified

    ClubMax Laser Projection Series

    Recall: Z-2092-2019 · Initiated July 10, 2019

    Recall

    Recall Number
    Z-2092-2019
    Event Number
    83438
    Firm
    Gk Photonics Inc
    FEI Number
    3006314809
    Product Code
    REA
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    July 10, 2019
    Address
    717 Ridge Dr, Glendale, CA, 91206-1752

    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.

    Distribution

    Unknown

    Quantity

    1291 total