BEUDAMED
    FDA Recall Terminated

    Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size

    Recall: Z-1871-2016 · Initiated March 28, 2016

    Recall

    Recall Number
    Z-1871-2016
    Event Number
    73704
    Firm
    Skytron, Div. The KMW Group, Inc
    FEI Number
    1825014
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 28, 2016
    Posted
    May 31, 2016
    Terminated
    July 25, 2017
    Address
    5085 Corporate Exchange Blvd SE, Grand Rapids, MI, 49512-5515

    Description

    Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size

    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 LLC initiated a voluntary recall of twenty-four monitor brackets used as a 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 3 equipment pendant /booms via telephone calls to customers, and written notices sent via certified USPS mail on 04/01/2016. All potentially affected users will receive a field correction notification directly from Skytron, LLC along with the contact information of their local Skytron distributor. Skytron distributors must contact identified users within the universe of affected products to schedule a time replace the affected monitor bracket(s). Skytron will provide a replacement of the monitor bracket. The replacement monitor bracket(s) and installation must be conducted by you, the Skytron distributor. The affected monitor bracket(s) and Service Report indicating that the monitor bracket(s) was replaced must be returned to Skytron. Please contact Larry Perez, Vice President of Technical Services, at 616-656-1187 or [email protected], or Thao Selleck, Complaint Resolution Analyst, at 616-656-6403 or [email protected] with any questions. For after-hours support, please call 1-800-SKYTRON.

    Distribution

    Worldwide distribution. US states: VA, VT, UT, GA, NJ, and IL; Japan.

    Quantity

    24