Events

Recall of Device Recall Agfa IMPAX CardioVascular Suite Results Management

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
    46889
  • Event Risk Class
    Class 2
  • Event Number
    Z-1349-2008
  • Event Initiated Date
    2008-02-22
  • Event Date Posted
    2008-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68392
  • 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
    PAC System/Report Management - Product Code LLZ
  • Reason
    Reporting differences: the outbound report software produces an outbound report (text version) which does not contain all the clinical content elements present in the pdf version of the report, also generated on the nuclear cardiology reporting module.
  • Action
    All five (5) sites utilizing this product were notified about the issue directly via telephone. An "Urgent Safety Notice" was sent via FED-EX to all the sites using the product on February 22, 2008. The letter describes the potential issue and mitigation. The recalling firm will also visit each site and make configuration changes to resolve this issue.

Device

Device Recall Agfa IMPAX CardioVascular Suite Results Management
  • Model / Serial
    Software Versions: 2.04.17, 2.04.19 and 2.04.20.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to five hospitals in DC, NY, OH, TN, and VA.
  • Product Description
    Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Software Versions: 2.04.17, 2.04.19 and 2.04.20, AGFA HealthCare, Westerly, RI
  • Manufacturer
    AGFA Corp.

Manufacturer

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