Events

Recall of NX8000

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

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
    112054
  • Event Risk Class
    II
  • Event Initiated Date
    2009-06-23
  • 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
    Under certain circumstances after opening and closing a study on a cms system while a study is still open on an in-room nx system a problem of image mis-up can occur on the in-room nx system.

Device

NX8000
  • Model / Serial
    Model Catalog: NX SOFTWARE 3.0.7000 (Lot serial: ); Model Catalog: NX SOFTWARE 2.0.8000 (Lot serial: ); Model Catalog: NX SOFTWARE 3.0.8000 (Lot serial: ); Model Catalog: NX SOFTWARE 2.0.7000 (Lot serial: )
  • Product Description
    NX 8000 WITH V. NX2008 OR NX.x.8000
  • Manufacturer
    AGFA HEALTHCARE CORPORATION

Manufacturer

AGFA HEALTHCARE CORPORATION
  • Manufacturer Address
    GREENVILLE
  • Manufacturer Parent Company (2017)
    Agfa-Gevaert NV
  • Source
    HC