Events

Recall of Device Recall IMPAX Cardiovascular Polling Procedure version 1.00.09

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
    50755
  • Event Risk Class
    Class 2
  • Event Number
    Z-0945-2009
  • Event Initiated Date
    2008-12-24
  • Event Date Posted
    2009-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76979
  • 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
    Image Processing Radiological System - Product Code LLZ
  • Reason
    Polling procedure may fail when multiple merge/split is carried out.
  • Action
    All sites potentially affected by this product were notified of the issue directly via telephone. Each site was directed to observe a ten minute polling window as an interim mitigation until the normal mitigation by software Service Update is performed at the site by Agfa Support. An Urgent Safety Notice was sent via FED-EX on/about 12/24/2008 to all sites. The letter describes the potential issue and both interim and formal mitigation. Acknowledgment, via FAX-Back, that the information was received and understood was requested from the sites.

Device

Device Recall IMPAX Cardiovascular Polling Procedure version 1.00.09
  • Model / Serial
    Serial number: KQRCPF9, Equipment number: 15013696, ; Serial number: BQWBZ81, Equipment number: 10281800; Serial number: FB5C561, Equipment number: 10262174; Serial number: USE708NBP3, Equipment number: 15003839; and Serial number: GN6Z1E1, Equipment number: 15009724.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of FL, IL, OR, SC, and SD.
  • Product Description
    IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000. || IMPAX Cardiovascular is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. The IMPAX Centric Polling Procedure provides a mechanism to ensure that patient demographic and merge/split operations performed on the IMPAX database utilizing the IMPAX Service Tool are captured and applied to the IMPAX CV database, in order to keep patient updates from the IMPAX database synchronized with the IMPAX CV database.
  • Manufacturer
    AGFA Corp.

Manufacturer

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