BEUDAMED
    FDA Enforcement Class II 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 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2446-2019
    Event ID
    83510
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Communications
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2019
    Initiation Date
    August 1, 2019
    Classification Date
    August 30, 2019
    Termination Date
    April 27, 2021
    Address
    571 Silveron Blvd, N/A, Flower Mound, TX, 75028, United States

    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.

    Code Info

    Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230.

    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