Events

Recall of Device Recall Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Communications.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79116
  • Event Risk Class
    Class 2
  • Event Number
    Z-0692-2018
  • Event Initiated Date
    2018-01-26
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161399
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Light, surgical, ceiling mounted - Product Code FSY
  • 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.

Device

Device Recall Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel
  • Model / Serial
    United States and Canada: Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230; International: Serial numbers 6145060-O11628 to 6176090-V14102
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
  • Manufacturer
    Stryker Communications

Manufacturer

Stryker Communications
  • Manufacturer Address
    Stryker Communications, 571 Silveron Blvd, Flower Mound TX 75028
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA