BEUDAMED
    FDA Recall Open, Classified

    HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

    Recall: Z-2166-2024 · Initiated March 28, 2024

    Recall

    Recall Number
    Z-2166-2024
    Event Number
    94839
    Firm
    Horiba Instruments Incorporated
    FEI Number
    3014443691
    Product Code
    REM
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 28, 2024
    Posted
    July 1, 2024
    Address
    20 Knightsbridge Rd, Piscataway, NJ, 08854-3913

    Description

    HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

    Reason

    HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the modular Instrument removed the primary light source and the excitation monochromator. A plastic cap was installed to plug the optical port, where a more durable beam stop should have been used. The defect may allow the class 4 laser beam to burn (or transmit) through the plastic cap to exit the protective enclosure.

    Action

    Horiba plans to issue an IMPORTANT ELECTRONIC PRODUCT RADIATION WARNING letter to notify affected customers. The notification will Identify the affected product involved, description of the defect, safety hazard imposed: and corrective actions, For questions, call (732) 623-8146.

    Distribution

    US Nationwide and Worldwide Distribution

    Quantity

    4 units