Z-1241-2008

Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island...

Name: Z-1241-2008 Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island...
Creator: AGFA Corp.
Published: 2007-06-21
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2007-06-21 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab... on 2007-06-21. The reason FDA records is "MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient". 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-1241-2008
Status: Terminated
Initiated: 2007-06-21
Posted: 2008-06-27
Terminated: 2008-08-04
Recalling firm: AGFA Healthcare Corp.
Product: Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.
Root cause tag: software
FDA root cause: Software design
Action: On 6/21-26/2007, AGFA Healthcare notified, via telephone, the affected consignees of the situation. On 7/2/2007, affected consignees were sent, via registered mail, an "Urgent Medical Device Correction" letter instructing them to: a) remove the affected software DICOMstore 2.04.40.00 and replace it with the prior software version, DICOMstore 2.04.34.02; and b) review patient ECG reports to determine if any patients were actually affected and to notify the firm. AGFA Healthcare also provided a customer service contact number (877) 777-2432.
Quantity in commerce: 43 units
Distribution: Worldwide Distributution - USA, including states of AZ, CA, DC, FL, IL, IN, KY, MA, ME, MN, MS, OH, OK, OR, NH, PA, SC, TN, TX, WI, and country of Canada.
Product codes and lots: DICOMstore, L9M8E, Software version: 2.04.40.00

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)