Events

Recall of Device Recall "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
    58166
  • Event Risk Class
    Class 2
  • Event Number
    Z-2137-2011
  • Event Initiated Date
    2011-03-04
  • Event Date Posted
    2011-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98571
  • 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
    NX - Image Acquisition and Processing Station - Product Code MQB
  • Reason
    When a radiographer is working on two open studies on an nx workstation and, in specific situations, a problem of image/annotation mix-up can occur on the nx system.
  • Action
    AGFA Corp. sent an "URGENT FIEL SAFETY NOTICE" letter via FED-EX to the customers on March 4, 2011. The letter describes the safety alert and mitigation. Customers were instructed to complete and return the Urgent Field Safety Notice Feedback Form by fax to 864-421-1664. For questions regarding this recall call 864-421-1815.

Device

Device Recall "NX" Modality Workstation
  • Model / Serial
    Software Versions: 2.0.8100, 3.0.8100, 2.0.8200, 3.0.8200, 2.0.8300, 3.0.8300, 2.0.8400, 3.0.8400, 2.0.8500, and 3.0.8500
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, GA, MS, ND, NM, NY, OK, PA, SC, SD, TX, and VA and the country of Canada
  • Product Description
    NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for the radiographer throughout the imaging process. NX communicates seamlessly with the hospital's picture archiving and communication system (PACS), radiology information system (RIS) and hospital information system (HIS). It is DICOM compliant and meets IHE guidelines.
  • Manufacturer
    AGFA Corp.

Manufacturer

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