Events

Recall of IMPAX Cardiovascular IMPAX CV12

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AGFA Healthcare 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
    72411
  • Event Risk Class
    Class 2
  • Event Number
    Z-0283-2016
  • Event Initiated Date
    2015-09-01
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140966
  • 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
    Customers have experienced impax cv software, specifically, demographics manager (dm), not producing correct pdf reports after the reports, at the time of physician signature, were correct.
  • Action
    An Urgent Field Safety Notice was sent to accounts via email on 9/1/2015. The letter described the safety alert. Customers were informed of the problem and that Service would be contacting them to arrange a date to deploy the corrective action and install the Service Update at their facility. An acknowledgement was included which was to be faxed back or emailed back to Agfa.

Device

IMPAX Cardiovascular IMPAX CV12
  • Model / Serial
    Model # L9M2100
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA, KY, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA and the country of Canada.
  • Product Description
    IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
  • Manufacturer
    AGFA Healthcare Corp.

Manufacturer

AGFA Healthcare Corp.
  • Manufacturer Address
    AGFA Healthcare Corp., 10 S Academy St, Greenville SC 29601-2632
  • Manufacturer Parent Company (2017)
    Agfa-Gevaert NV
  • Source
    USFDA