Recall of DXG Digitizer

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

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    Packaging was switched between a dx-g digitizer and a dx-m digitizer, resulting in the wrong product, which is not sold in the us, being shipped to the consignee.
  • Action
    Agfa halted Installation of the incorrect unit, and the unit was sent to Agfa warehouse in Carlstadt, NJ, where it is being held in quarantine for export.


  • Model / Serial
    Model 5170/100
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationside Distribution: to NJ.
  • Product Description
    DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.
  • Manufacturer


  • Manufacturer Address
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source