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-2446-2019 · Initiated August 1, 2019

    Recall

    Recall Number
    Z-2446-2019
    Event Number
    83510
    Firm
    Stryker Communications
    FEI Number
    3002975342
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 1, 2019
    Posted
    August 30, 2019
    Terminated
    April 27, 2021
    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 weld.

    Action

    The recalling letter issued letters on 8/1/2019 via Fed Ex.

    Distribution

    Distribution was made to CA, CO, CT, FL, GA, IL, IN, MD, MI, MN, MO, NC, NH, NJ, NY, OH, PA, SC, TN, TX, and WI. There was foreign distribution to Canada and Germany. There was no government/military distribution.

    Quantity

    52 devices