Events

Recall of Device Recall Results Management (RM) Reporting Module

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
    60154
  • Event Risk Class
    Class 2
  • Event Number
    Z-0211-2012
  • Event Initiated Date
    2011-06-06
  • Event Date Posted
    2011-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104617
  • 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
    Improper merging of impax cardiovascular results management (rm) reports causes the signed report to become unavailable.
  • Action
    AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated May 27, 2011, via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to carry out a merge post finalization of an RM reports. If it is necessary to modify a finalized report, AGFA recommends that they make the modification through one of the following actions: Amend the report through the RM interface, or Call AGFA Service to change the status of the report to "preliminary" and then proceed with the finalization of the report. AGFA issued an Acknowledgment, via FAX- Back that the information was received and understood to affected customers. For any questions customers were instructed to contact their AGFA Healthcare Service at 877-777-2432.

Device

Device Recall Results Management (RM) Reporting Module
  • Model / Serial
    Software Versions: RM2.04.37.04 to RM 7.8 SU2 (RM 2.04.37.04 is a version prior to CV 7.2 release).
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada
  • Product Description
    IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2 || The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and 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