BEUDAMED
    FDA Recall Terminated

    ***REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use***CONMED LINVATEC, CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA*** Catalog No Product VPN6528 Articulating Arm, Secondary Flat Panel. 690-0024-00 Arm, Wall Mount, Flat Screen, GCX For mounting and positioning of flat screen monitors.

    Recall: Z-1893-2011 · Initiated September 17, 2010

    Recall

    Recall Number
    Z-1893-2011
    Event Number
    58009
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    KQM
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 17, 2010
    Posted
    April 5, 2011
    Terminated
    May 17, 2011
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    ***REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use***CONMED LINVATEC, CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA*** Catalog No Product VPN6528 Articulating Arm, Secondary Flat Panel. 690-0024-00 Arm, Wall Mount, Flat Screen, GCX For mounting and positioning of flat screen monitors.

    Reason

    If the VHM Arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement.

    Action

    An Urgent Service Bulletin Notification was mailed to each ConMed Linvatec customer who received the affected product. The letter identified the affected product and stated the reason for notification. The letter asks customers to review the GCX Corporation Service Bulletins and updated Installation/User Manual. ConMed Linvatec recommends that customers periodically check the VHM Arm to see that it is functioning properly. In addition "Sudden Movement" stickers, provided by GCX, were also included to all consignees as part of the mailing. If customers in the US have questions or need technical support, they can contact ConMed Linvatec Endoscopy Customer Service at 888-292-0100 or e-mail [email protected].

    Distribution

    Worldwide Distribution -- Australia, Canada, Morocco, Saudi Arabia, Taiwan, Province of China, and throughout the U.S.

    Quantity

    373