Z-0366-2010

AGFA IMPAX HeartStation ECG Management System

Name: Z-0366-2010 AGFA IMPAX HeartStation ECG Management System
Creator: AGFA Corp.
Published: 2009-05-07
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2009-05-07 / Terminated

FDA source

AGFA Corp. began a recall of AGFA IMPAX HeartStation ECG Management System on 2009-05-07. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0366-2010
Status: Terminated
Initiated: 2009-05-07
Posted: 2009-11-18
Terminated: 2010-07-27
Recalling firm: AGFA Healthcare Corp.
Product: AGFA IMPAX HeartStation ECG Management System.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
FDA root cause: Other
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.
Quantity in commerce: 9 units
Distribution: CA, KY, MA, NY, OH, SC, Belgium, Italy and Singapore
Product codes and lots: 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 code LLZ

K050858Class IIAscentia Heartstation ECG Management SystemHeartlab, Inc. / cleared 2005-06-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)