Events

Recall of RADIOMAT B+ NIF 8 X 10

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AGFA HEALTHCARE INC..

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
    93982
  • Event Risk Class
    III
  • Event Initiated Date
    2014-07-17
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The reason for this recall/correction/removal is to inform dealers of defective product recently shipped to their facilities and to explain that when processed some sheets will show a pre-exposure fog. the removal request is to attempt to quarantine the affected material prior to it being shipped for customer use.

Device

RADIOMAT B+ NIF 8 X 10
  • Model / Serial
    Model Catalog: EBA45000 (Lot serial: 79390074); Model Catalog: EK8DG000 (Lot serial: 79380052)
  • Product Description
    RADIOMAT B+ NIF 8 X 10
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

AGFA HEALTHCARE INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Agfa-Gevaert NV
  • Source
    HC