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
    66424
  • Event Risk Class
    Class 2
  • Event Number
    Z-0035-2014
  • Event Initiated Date
    2013-09-19
  • Event Date Posted
    2013-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122368
  • 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
    Picture Archiving and Communication System (PACS). - Product Code LLZ
  • Reason
    System downtime and/or slow performance may result if software in use is an old version of impax and is not at current supported levels.
  • Action
    An "URGENT FIELD SAFETY NOTICE" letter was sent via email to the consignees on 9/19/2013, Acknowledgement, via FAX-Back or email, that the information was received and understood has been requested from the consignees. The letter specifically describes the safety alert for the device, informs consignees of the problem and recommends the upgrades for IMPAX and Oracle.

Device

IMPAX
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.
  • Product Description
    IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
  • Manufacturer
    AGFA Corp.

Manufacturer

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