Events

Recall of Radiomat Lightweight Cassettes

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
    Recall
  • Event ID
    32911
  • Event Risk Class
    Class 2
  • Event Number
    Z-1404-05
  • Event Initiated Date
    2005-01-26
  • Event Date Posted
    2005-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41064
  • 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
    Cassette, Radiographic Film - Product Code IXA
  • Reason
    Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.
  • Action
    Consignees were notified by letter on/about 07/29/2005.

Device

Radiomat Lightweight Cassettes
  • Model / Serial
    Product Code: EHYG2, Model: 14x17 Green RE 400 Screens and Cassettes, Product Code: EHYCT, Model: 14x17 Green RE 100 Screens and Cassettes, Product Code: EHX5C, Model: 14x17 Blue RE 800 Screens and Cassettes,  Batch number are a combination of 4 letters/numbers xxyy, where xx varies alphabetically form 6N and 6Z and from 7A to &N; and yy is a number from 01 through 31. Batch numbers are located both on the cassette shell and on the outer label.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada
  • Product Description
    Radiomat Lightweight Cassettes
  • Manufacturer
    AGFA Corp.

Manufacturer

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