Events

Recall of Device Recall Agfa IMPAX HeartStation ECG Management System

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
    53604
  • Event Risk Class
    Class 3
  • Event Number
    Z-0366-2010
  • Event Initiated Date
    2009-05-07
  • Event Date Posted
    2009-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85969
  • 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
    electrocardiograph - Product Code LLZ
  • Reason
    Heartstation does not refresh content changes to the pdf reports that are printed emailed or faxed from the index page. this may lead to a discrepancy in patient demographics between what is displayed in the heartstation client interface and the report delivered to the consumer. questions are being directed to the local agfa representative; the contact information was included in the letter.
  • Action
    An Urgent Safety Notice was sent via FED-EX to all the sites with the affected units (a total of 6) on May 7, 2009. The three foreign accounts were notified by letter on May 14, 2009. The letter describes the potential issue and mitigation. Acknowledgment via FAX-Back that the information was received and understood was requested from the sites. Customers who use the print, email, fax functionality of this product were verbally notified of the defect and they have been advised of a workaround. In the notice letter, Agfa HealthCare is also providing customers with the recommended workaround. The workaround is to only print from the Viewer screen or to print the ECG once confirmed. The Viewer screen, however, does not allow the user to print batches of reports as does the Index screen. Questions about this matter are being directed to the local Agfa HealthCare representative.

Device

Device Recall Agfa IMPAX HeartStation ECG Management System
  • Model / Serial
    Model number HeartStation 1.1 60+00091179 to 60+0091186; HeartStation Core Server 60+00091211; CV HeartStation EZKT7000, L9NBN000, EZKC000, L9NAL000, EZKWE000 and L9M9G000.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, KY, MA, NY, OH, SC, Belgium, Italy and Singapore
  • Product Description
    AGFA IMPAX HeartStation ECG Management System.
  • Manufacturer
    AGFA Corp.

Manufacturer

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