BEUDAMED
    FDA Enforcement Class II Terminated

    Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms

    Recall: Z-0655-2016 · Reported January 20, 2016

    Enforcement

    Recall Number
    Z-0655-2016
    Event ID
    72897
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Skytron, Div. The KMW Group, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 20, 2016
    Initiation Date
    December 2, 2015
    Classification Date
    January 14, 2016
    Termination Date
    July 19, 2016
    Address
    5085 Corporate Exchange Blvd Se, N/A, Grand Rapids, MI, 49512-5515, United States

    Description

    Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms

    Reason

    The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Over time and with use the threaded rod hardware material can weaken and detach from the bracket. A display interface falling from its mounting location may result in injury to the patient or provider.

    Code Info

    Model Number(s): H8-010-50-FC2-LH and H8-010-50-FC2-RH. VESA plates distributed from 09/26/08 to 04/30/13.

    Distribution

    Worldwide Distribution - US including WI, TX, FL, NC, MD, OH, AZ, CA, UT, MT, OK, HI, CO, WY, MO, NJ, IL, NY, MA, IA, DE, PA, MI, IN, and WV and Internationally to Canada, and Japan.

    Quantity

    286