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-0692-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0692-2018
    Event ID
    79116
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Communications
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    January 26, 2018
    Classification Date
    February 23, 2018
    Termination Date
    March 19, 2019
    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 (missing or incomplete) weld.

    Code Info

    United States and Canada: Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230; International: Serial numbers 6145060-O11628 to 6176090-V14102

    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