Events

Recall of Device Recall LCD Display Monitor

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

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
    72390
  • Event Risk Class
    Class 2
  • Event Number
    Z-0227-2016
  • Event Initiated Date
    2015-05-28
  • Event Date Posted
    2015-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140891
  • 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
    Camera, surgical and accessories - Product Code KQM
  • Reason
    User settings were no longer on the monitor's memory after these systems were powered off and back on.
  • Action
    Barco sent an "Urgent Medical Device Correction Notice" dated May 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notice contained "Interim Corrective Action" and information about a "Final Corrective Action". The notice included a reply notice to be sent back to Barco and also requested a sub-recall. For further questions, please call (678) 475-8156.

Device

Device Recall LCD Display Monitor
  • Model / Serial
    Model MDSC-2224 (24 inch) with part numbers - K9307916 - 991932387121, K9307919 - 991932387131, K9307912 - 991932387071, K9307913 - 991932387081; Model MDSC-2226 (26 inch) with part numbers - K9307906 - 991932387011, K9307907 - 991932387031, K9307908 - 991932387021, 991932387041, 991932387061, 991932387111, 991932387141, 991932389071, 991932389081, 991932389091; Model MDSC-2242 (42 inch) with part numbers - K9307914 - 991932387091, K9307915 - 991932387101
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : AZ, CA, FL, GA, IL, MA, NE, NJ, OH, OR and TX., and Internationally to Canada.
  • Product Description
    Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
  • Manufacturer
    Barco Inc.

Manufacturer

Barco Inc.
  • Manufacturer Address
    Barco Inc., 3059 Premiere Pkwy, Duluth GA 30097-4905
  • Manufacturer Parent Company (2017)
    Barco Nv
  • Source
    USFDA