Z-1349-2008

Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog...

Name: Z-1349-2008 Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog...
Creator: AGFA Corp.
Published: 2008-02-22
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2008-02-22 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Software Versions: 2.04.17, 2.04.19 and... on 2008-02-22. The reason FDA records is "Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1349-2008
Status: Terminated
Initiated: 2008-02-22
Posted: 2008-03-31
Terminated: 2010-07-27
Recalling firm: AGFA Healthcare Corp.
Product: Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Software Versions: 2.04.17, 2.04.19 and 2.04.20, AGFA HealthCare, Westerly, RI
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology Reporting Module.
Root cause tag: software
FDA root cause: Software design
Action: All five (5) sites utilizing this product were notified about the issue directly via telephone. An "Urgent Safety Notice" was sent via FED-EX to all the sites using the product on February 22, 2008. The letter describes the potential issue and mitigation. The recalling firm will also visit each site and make configuration changes to resolve this issue.
Quantity in commerce: 5 units
Distribution: Nationwide to five hospitals in DC, NY, OH, TN, and VA.
Product codes and lots: Software Versions: 2.04.17, 2.04.19 and 2.04.20.

Product code LLZ

K050228Class IIAgfa Heartlab CardiovascularHeartlab, Inc. / cleared 2005-02-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)