BEUDAMED
    FDA Recall Open, Classified

    Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

    Recall: Z-1569-2020 · Initiated March 5, 2020

    Recall

    Recall Number
    Z-1569-2020
    Event Number
    85252
    Firm
    Skytron, Div. The KMW Group, Inc
    FEI Number
    1825014
    Product Code
    FQO
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 5, 2020
    Address
    5085 Corporate Exchange Blvd SE, Grand Rapids, MI, 49512-5515

    Description

    Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

    Reason

    Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.

    Action

    Skytron customer notification letters mailed on 3/5/2020. Distributors received notification via email on 3/5/2020. Letter states reason for recall, health risk and action to take: 1.Identify and inspect your 3FCM1 monitor bracket(s). 1508T719-00-0-0120 2.Remove from service any bracket with noticeable physical distortion or cracking around the welded area. 3.Skytron authorized representatives have been directed to contact and schedule a service visit within a 30-day window of time. The contact information for your authorized representative is: Johnsons Medical, Inc. Donna Johnson, (801) 768-4411 Please contact Erin Woolf, at 616-656-2998 or [email protected] with any questions. For after-hours support, please call 1-800-SKYTRON.

    Distribution

    AZ, CO, GA, IL, MI, MN, NJ, PA, VA, VT

    Quantity

    43 units