BEUDAMED
    FDA Enforcement Class II Ongoing

    Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

    Recall: Z-1663-2025 · Reported April 30, 2025

    Enforcement

    Recall Number
    Z-1663-2025
    Event ID
    96581
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    IHB OPERATIONS B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 30, 2025
    Initiation Date
    March 27, 2025
    Classification Date
    April 23, 2025
    Address
    Floresstraat 52, N/A, Zwolle, N/A, N/A, Netherlands

    Description

    Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

    Reason

    The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column.

    Code Info

    UDI/DI 10841736116071, All Serial Numbers

    Distribution

    US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, ID, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NM, NY, PA, TN, TX, UT, VA, WI, WV.

    Quantity

    112 units