Recall Z-1242-2008 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891
| Date | Jun 27, 2008 (initiated Jul 27, 2007) |
| Status | Terminated |
| Reason | Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured. |
| 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' |
| Quantity | 6 units |
| Distribution | Nationwide Distribution -- USA including states of GA, NH, NY and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |