Events

Recall of Device Recall IMPAX CV Reporting NonInvasive Vascular (NIV)/Results Management (RM) NIV

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
    62534
  • Event Risk Class
    Class 2
  • Event Number
    Z-2069-2012
  • Event Initiated Date
    2012-07-10
  • Event Date Posted
    2012-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110871
  • 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
    When users selected "left stenosis" in the "graft duplex conclusion" section in impax cv reporting non-invasive(niv) module, "right stenosis" appeared in the sentence display within the printed representation of the report.
  • Action
    AGFA Healthcare sent an Urgent Field Safety Notice dated July 10, 2012, to all affected consignees indicating that a representative from the IMPAX CV product management or professional services team would be contacting them to perform a review of their system. For questions customers were asked to call 401-604-2180. For questions regarding this recall call 864-421-1754.

Device

Device Recall IMPAX CV Reporting NonInvasive Vascular (NIV)/Results Management (RM) NIV
  • Model / Serial
    Software Version: RM 2.03 to 2.08, NIV 1.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including IN, SC, OH, TX
  • Product Description
    IMPAX CV Reporting || The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.
  • Manufacturer
    AGFA Corp.

Manufacturer

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