BEUDAMED
    FDA Enforcement Class II Ongoing

    EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.

    Recall: Z-0870-2020 · Reported February 5, 2020

    Enforcement

    Recall Number
    Z-0870-2020
    Event ID
    84378
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Energetiq Technology Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    February 5, 2020
    Initiation Date
    September 27, 2019
    Classification Date
    January 29, 2020
    Address
    7 Constitution Way, N/A, Woburn, MA, 01801-1024, United States

    Description

    EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.

    Reason

    On September 27, 2019 Energetiq Technology (the manufacturer) discovered a problem with their EQ-400-RH-QZ and EQ-400-LH-BK products during routine manufacturing functional testing. It was noted that a safety interlock within the lamp does not function in a reliable manner to shut down the system if the laser collimator is removed from the lamp while the system is operating. This is a potential safety hazard for anyone working on or nearby the lamp.

    Code Info

    The defect concerns a total of fifteen (15) of our EQ-400 products. manufactured between June 3, 2016 and September 26, 2019.

    Distribution

    Worldwide Distribution.

    Quantity

    15