Recall of Device Recall Radiomat

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 3
  • 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
    Medical Screen X-Ray Film - Product Code JAC
  • Reason
    A localized fog pattern appears on the film.
  • Action
    Consignees were notified by telephone on 02/16/2006.


  • Model / Serial
    Product Code: EK8JR, Manufacturing Batch or Lot: 79360104 and Product Code: EK8DG, Manufacturing Batch or Lot: 79360104
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    AL, AZ, CA, CO, FL, GA, IN, MA, MI, NC, NJ, NY, OR, SC, TN, TX, WA, VA and Canada
  • Product Description
    Radiomat¿ SG, 11x14, Medical Screen Film, X-ray Film, 100 Sheet Box and 14x17, 100 Sheet Box
  • Manufacturer


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