Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891
- Company
- Agfa Corp.
- Recall Initiated
- July 27, 2007
- Posted
- June 27, 2008
- Terminated
- October 10, 2008
- Recall Number
- Z-1242-2008
- Quantity
- 6 units
- Firm Location
- Greenville, SC
Reason for Recall
Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.
Distribution
Nationwide Distribution -- USA including states of GA, NH, NY and TX
Lot / Code Info
Results Management Model Number: L58RZ and L9MWQ, Version 2.03 and 2.04
Root Cause
Software design
Action Taken
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.