Events

Recall of Device Recall IMPAX Cardiovascular (CV) Reporting

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
    62646
  • Event Risk Class
    Class 2
  • Event Number
    Z-2184-2012
  • Event Initiated Date
    2012-07-27
  • Event Date Posted
    2012-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111260
  • 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
    Content entered into the "conclusions" free text box on the report writer screen was not represented on the final printed report.
  • Action
    AGFA Healthcare sent an URGENT FIELD SAFETY NOTICE dated July 27, 2012, to all affected customers. The letter described the safety alert and mitigation. Customer were asked to complete the Acknowledgment form and fax back to 864-421-1664 that the information was received and understood. For questions customers were instructed tol call 401-604-2180. For questions regarding this recall call 864-421-1754.

Device

Device Recall IMPAX Cardiovascular (CV) Reporting
  • Model / Serial
    Model # L9M2100 - All Software versions of IMPAX CV Reporting
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada
  • Product Description
    IMPAX Cardiovascular (CV) Reporting || Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
  • Manufacturer
    AGFA Corp.

Manufacturer

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