BEUDAMED
    FDA Recall Terminated

    Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.

    Recall: Z-0692-2018 · Initiated January 26, 2018

    Recall

    Recall Number
    Z-0692-2018
    Event Number
    79116
    Firm
    Stryker Communications
    FEI Number
    3002975342
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 26, 2018
    Terminated
    March 19, 2019
    Address
    571 Silveron Blvd, Flower Mound, TX, 75028

    Description

    Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.

    Reason

    The mounts on the monitor may have an insufficient (missing or incomplete) weld.

    Action

    The recalling firm issued letters dated 1/26/2018 via FedEx on 1/26/2018 explaining the issue and the potential adverse consequences.

    Distribution

    Distribution was made to medical facilities nationwide, including government and military distribution. Foreign distribution was made to Canada, Belgium, China, United Kingdom, UAE, France, Germany, Spain, Japan, Ecuador, and Russia.

    Quantity

    850