BEUDAMED
    FDA Recall Open, Classified

    GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.

    Recall: Z-1290-2023 · Initiated September 23, 2022

    Recall

    Recall Number
    Z-1290-2023
    Event Number
    91969
    Firm
    GAGA PRO LIGHTING EQUIPMENT CO.
    FEI Number
    3013936259
    Product Code
    REA
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    September 23, 2022
    Posted
    March 29, 2023
    Address
    1238 Longjiao Road, Industrial Area Guangzhou China

    Description

    GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.

    Reason

    GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products.

    Action

    GaGa. will send a Customer Notification letter to the affected customers by certified mail. The letter will identify the affected product, problem and actions to be taken. GAGA lighting will offer free upgrades to update your GAGA Laser projector to the current FDA requirements. Alternatively, you may choose to ship your laser projector to GAGA Lighting s U.S. agent, Laser Display Company, in order to get it fixed. GAGA Lighting will pay for shipping costs. GAGA Lighting, without charge, will bring the product into compliance with each applicable Federal standard for laser products.

    Distribution

    US Nationwide Distribution

    Quantity

    11 units