Events

Recall of CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x)

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
    34088
  • Event Risk Class
    Class 2
  • Event Number
    Z-0353-06
  • Event Initiated Date
    2005-11-18
  • Event Date Posted
    2006-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43096
  • 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
    System, Image Processing, Radiological - Product Code LLZ
  • Reason
    Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.
  • Action
    Consignees will be notified by letter on/about December 1, 2005 and offered upgraded software.

Device

CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Softwar...
  • Model / Serial
    Software versions: ADC QS 2.0, CR QS 3.O.207, CR QS 3.O.210, CR QS 3.0.210SU1, CRQS 3.0.229, Centricity CR Online Processing software 2.x.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x)
  • Manufacturer
    AGFA Corp.

Manufacturer

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