BEUDAMED
    FDA Recall 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 · Initiated December 2, 2015

    Recall

    Recall Number
    Z-0655-2016
    Event Number
    72897
    Firm
    Skytron, Div. The KMW Group, Inc
    FEI Number
    1825014
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 2, 2015
    Posted
    January 14, 2016
    Terminated
    July 19, 2016
    Address
    5085 Corporate Exchange Blvd Se, Grand Rapids, MI, 49512-5515

    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.

    Action

    Skytron sent an Urgent Medical Device Recall letter dated December 02. 2015, to all affected customers via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions were instructed to contact at 616-656-2900 with any questions. For after-hours support, please call 1-800-SKYTRON.

    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