AGFA Corp. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
AGFA Corp.
Lot Codes / Batch Numbers
DICOMstore, L9M8E, Software version: 2.04.40.00
Products Sold
DICOMstore, L9M8E, Software version: 2.04.40.00
AGFA Corp. is recalling Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Wester due to MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, IL, IN, KY, ME, MA, MN, MS, NH, OH, OK, OR, PA, SC, TN, TX, WI, DC
Page updated: Jan 10, 2026