Recall of CR DX-S, DX-S, Computed radiography system (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
    computed radiography system digitizer - Product Code MQB
  • Reason
    Corrupted image after system start; corrupted image after workflow interruption; an erasure unit problem can cause system to stop.
  • Action
    Consignees were notified at the time of upgrading. The software was upgraded on 11/3/2005, 12/19/2005 and 12/28/2005. A Mandatory Service Bulletin, No. 11, explaining the issues was shared with the accounts.


  • Model / Serial
    CR DX-S: Units with Serial numbers SN1001-SN1079, Software versions: STR1102B and below.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    DC, MS, OR--three states
  • Product Description
    CR DX-S, DX-S, Computed radiography system (Digitizer)
  • Manufacturer


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