AGFA Corp. Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891
Brand
AGFA Corp.
Lot Codes / Batch Numbers
Results Management Model Number: L58RZ and L9MWQ, Version 2.03 and 2.04
Products Sold
Results Management Model Number: L58RZ and L9MWQ, Version 2.03 and 2.04
AGFA Corp. is recalling Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., W due to Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.
Recommended Action
Per FDA guidance
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.
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 noticePage updated: Jan 10, 2026