Events

Recall of Device Recall CRS

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
    57821
  • Event Risk Class
    Class 2
  • Event Number
    Z-1434-2011
  • Event Initiated Date
    2011-01-27
  • Event Date Posted
    2011-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97506
  • 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
    Echocardiography volume measurements performed within crs were not reflected correctly in associated results management (rm) reports.
  • Action
    The firm, AGFA Healthcare, sent a "Safety Notice" dated January 27, 2011 to all customers. The notice described the product, problem and action to be taken by firm and customer. AGFA informed the customers that a software upgrade was made between December 2008 and February 2010 and instructed the customers to distribute this information to all individuals within their facility and to complete and return the attached URGENT SAFETY NOTICE FEEDBACK FORM via fax to 864-421-1664 or email to debbie.norris@agfa.com. Note: Service Bulletin DD+DIS100.09E, was issued March 2009 and an upgrade from Software Versions 2.12.05 through 2.14.03.SU1 to Software Version CRS 2.14.03.SU2 was required for the impacted sites. Most identified consignees/customers required the software upgrade, but some consignees/customers had already been upgraded prior to the event and did not require additional upgrades. If you have any questions about this matter, please contact the Post Market/QARA North America via email at debbie.norris@agfa.com or call at 864-421-1754.

Device

Device Recall CRS
  • Model / Serial
    Software Versions 2.12.05 - 2.14.03.SU1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and country of: Canada
  • Product Description
    Cardiovascular Review Station || The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting.
  • Manufacturer
    AGFA Corp.

Manufacturer

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