BEUDAMED
    FDA Recall Open, Classified

    Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

    Recall: Z-1309-2022 · Initiated June 2, 2022

    Recall

    Recall Number
    Z-1309-2022
    Event Number
    90400
    Firm
    Skytron, Div. The KMW Group, Inc
    FEI Number
    1825014
    Product Code
    FQO
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    June 2, 2022
    Address
    5085 Corporate Exchange Blvd SE, Grand Rapids, MI, 49512-5515

    Description

    Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

    Reason

    Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom.

    Action

    On June 2, 2022, the firm sent out Urgent Medical Device Correction letters to affected customers. Customers were instructed to identify their GCX Channel Mounting Accessories used with Ergon 3 booms. Customers should inspect their mounting accessories. If the user sees that the channel is tilted on the VST clamp, this could indicate that the screws or tension knob have loosened. Remove the device from service if you find evidence that it may fail. Skytron authorized representatives will contact customers to schedule a service visit. Please contact quality at [email protected] with any questions.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada and Japan.

    Quantity

    731