Events

Recall of Device Recall Agfa Healthcare Corp. NX 2008 Central Monitoring System

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
    52679
  • Event Risk Class
    Class 2
  • Event Number
    Z-1889-2009
  • Event Initiated Date
    2009-06-22
  • Event Date Posted
    2009-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83625
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code LLZ
  • Reason
    After opening and closing a study on a central monitoring system while a study is still open on an in-room nx system, a problem of image mix-up can occur on the in-room nx system.
  • Action
    An "Urgent Safety Notice" was sent to all potentially affected sites on/about June 22, 2009 to make them aware of the issue. A FAX Back form is requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A software service update to solve this issue is expected to be released by August 15, 2009. A Mandatory Service Bulletin will be deployed to correct the problem in the software. If you have questions, please contact Agfa Healthcare at 1-800-581-2432 prompts 1, 3 and then 2 for CR Support.

Device

Device Recall Agfa Healthcare Corp. NX 2008 Central Monitoring System
  • Model / Serial
    NX Software versions: 2.0. 7000, 3.0.7000, 2.0.8000 and 3.0.8000.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide - IL, PA, TX, Canada, Europe, Asia Pacific and Latin America
  • Product Description
    NX 2008 Central Monitoring System (CMS). Product code: E2FB6 || Agfa's Computed Radiography Systems with NX Workstations are intended for use in || providing diagnostic quality images to aid the physician with diagnosis.
  • Manufacturer
    AGFA Corp.

Manufacturer

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