Z-1242-2008

Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly...

Name: Z-1242-2008 Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly...
Creator: AGFA Corp.
Published: 2007-07-27
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2007-07-27 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891 on 2007-07-27. The reason FDA records is "Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured". 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-1242-2008
Status: Terminated
Initiated: 2007-07-27
Posted: 2008-06-27
Terminated: 2008-10-10
Recalling firm: AGFA Healthcare Corp.
Product: Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.
Root cause tag: software
FDA root cause: Software design
Action: On 7/27/2007 to 8/16/2007, AGFA Healthcare notified, via telephone, consignees of the situation. On 7/27/2007, a formal customer notification letter was sent to affected consignees, providing them with a respective listing of patients that were potentially affected. AGFA informed the consignees that the firm would correct any incorrect patient ECG data. AGFA also informed their consignees that they would provide a configuration update to correct the problem. A notification confirmation form to be return to the firm was also attached to the notification letter, which also provided the firm's customer service number: (877) 777-2432.
Quantity in commerce: 6 units
Distribution: Nationwide Distribution -- USA including states of GA, NH, NY and TX
Product codes and lots: Results Management Model Number: L58RZ and L9MWQ, Version 2.03 and 2.04

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)