Events

Recall of Device Recall IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting

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
    64656
  • Event Risk Class
    Class 2
  • Event Number
    Z-1070-2013
  • Event Initiated Date
    2013-03-15
  • Event Date Posted
    2013-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116722
  • 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
    Baseline pulmonary capillary wedge (pcw) pressure values from impax cv reporting cardiac catheterization module were not correctly transferring into the hospital's electronic health record (ehr) system.
  • Action
    AGFA sent an "URGENT FIELD SAFETY NOTICE" letter dated March 15, 2013 to the consignees who use the IMPAX CV Reporting tool described for this issue. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 877-777-2432, referencing HQ_10020006 for questions regarding this notice.

Device

Device Recall IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting
  • Model / Serial
    Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.
  • Product Description
    IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. || Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
  • Manufacturer
    AGFA Corp.

Manufacturer

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