Events

Recall of IMPAX

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
    36203
  • Event Risk Class
    Class 2
  • Event Number
    Z-0033-2007
  • Event Initiated Date
    2006-08-08
  • Event Date Posted
    2006-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48186
  • 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
    mammography - Product Code LLZ
  • Reason
    Failed cad displayed as 'no findings'.
  • Action
    Consignees were notified by letter on/about 08/08/2006.

Device

IMPAX
  • Model / Serial
    Diagnostic Workstation/Impax 5.2/with CAD Capability/Flat Panel 60+00024433,  Diagnostic Workstation/Impax 5.2/with CAD Capability/CRT: 60+00024432 and  Clinical Review Station/Impax 5.2/with CAD Capability/Flat Panel: 60+00024438. Software version Impax 5.2.2 sites using CAD.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    IMPAX¿ 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
  • Manufacturer
    AGFA Corp.

Manufacturer

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