Events

Recall of CR NX Modality Workstation

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
    36635
  • Event Risk Class
    Class 2
  • Event Number
    Z-0219-2007
  • Event Initiated Date
    2006-09-01
  • Event Date Posted
    2006-11-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49036
  • 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
    Computed Radiography System - Product Code MBQ
  • Reason
    Users may experience one or more of four (4) problems; 1. image quality problem with full leg full spine exams. 2. unable to print 2 or more images on 1 film. 3. possible image loss when printing. 4. study date and time not showing up on imexius web.
  • Action
    A Service Bulletin to address the issues was created on 09/01/2006. Customers were notified of the plans to upgrade via telephone and email on 10/13/2006.

Device

CR NX Modality Workstation
  • Model / Serial
    NX Workstation Software is sold in the following packages: 60+0026406, 60+00026407, 60+00026408, 60+00026857, 60+00026858, 60+00026410, ES885. Software versions: NX 1.0.2402 and NX 1.0.2405
  • Product Classification
    Physical Medicine Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).
  • Manufacturer
    AGFA Corp.

Manufacturer

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