Recall of Device Recall Agfa, CR DXS System

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
    Fluoroscopic X-ray system - Product Code MQB
  • Reason
    Three separate issues involving the agfa dx-s cr system, were detected that could lead to an image loss.
  • Action
    Consignees were notified by letter on/about 06/28/2006.


  • Model / Serial
    Units with Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    CA, DC, FL, MN, MI, MS, OR.
  • Product Description
    CR DX-S, Image Intensified Fluoroscopic X-ray system.
  • Manufacturer


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