Events

Recall of IMPAX 6.5

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
    58565
  • Event Risk Class
    Class 2
  • Event Number
    Z-2246-2011
  • Event Initiated Date
    2011-04-05
  • Event Date Posted
    2011-05-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99598
  • 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
    Software issue that occurs after dictation of a study.
  • Action
    Agfa Corp. sent an "URGENT SAFETY NOTICE" customer letter via Agfa email to customers on 4/14/2011, along with a "URGENT SAFETY NOTICE FEEDBACK FORM," The letter identified the product , the problem, and the action to be taken by the customer. It was discovered a software issue in the IMPAX 6.5. The upgrade has already been released to address the software problem. Customers were instructed to fax back the feedback form as soon as possible to (864) 421-1664. If you have any questions, please contact your local Agfa Healthcare organization.

Device

IMPAX 6.5
  • Model / Serial
    35A2Y000, 35AWO000, 5N2N4004, 5NP9X001, 5NSMY000, 5OHXO000, 5QFWU000, E5KN2002, ETQ55000, EU5P6000, EYMFF000, F8AM4771, L18HH000, L2CEW000, L41KH000, L5N26000, L5N4B000, L5N5D000, L5P6O000, L5PD1000, L6S8E000, L8L5U000, L8VHQ000, L9HGC000, LEFG2504, LVTB7007
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- including states of WI, and SC.
  • Product Description
    IMPAX 6.5 Client Software. || IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range of users on any appropriate, networked workstation they have access to.
  • Manufacturer
    AGFA Corp.

Manufacturer

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