BEUDAMED
    FDA Recall Open, Classified

    Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32

    Recall: Z-1861-2021 · Initiated May 11, 2021

    Recall

    Recall Number
    Z-1861-2021
    Event Number
    87939
    Firm
    Skytron, Div. The KMW Group, Inc
    FEI Number
    1825014
    Product Code
    FQO
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 11, 2021
    Posted
    June 15, 2021
    Address
    5085 Corporate Exchange Blvd SE, Grand Rapids, MI, 49512-5515

    Description

    Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32

    Reason

    Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or staff

    Action

    Skytron issued Urgent Medical Device Correction notice on 5/11/21. Letter states reason for recall, health risk and action to take: Identify your FS32 monitor bracket(s). Serial numbers can be found on the UDI label located on the back of the bracket. Inspect your FS32 monitor bracket(s) per the instructions on the final page of this document. Remove from service any bracket where evidence is identified that the device may fail. Skytron authorized representatives have been directed to contact you and schedule a service visit. Please contact Erin Woolf, at 616-656-2998 or [email protected] with any questions. ***UPDATED 12/10/21*** On November 22, 2021, the firm sent updated letters due to an expansion of the recall scope. Revision 3 models of the FS32 Monitor Bracket were added to the recall. Customer instructions remain the same.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Japan.

    Quantity

    278 units US; 7 units OUS