Recall Z-1676-2011 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
| Date | Mar 16, 2011 (initiated Feb 10, 2011) |
| Status | Terminated |
| Reason | A discrepancy in the validation testing which resulted in the product not performing as intended. |
| Root cause | Device Design |
| Action | AGFA sent an "URGENT SAFETY NOTICE" letter dated 2/10/11 via FED-EX to the customer. The letter included an acknowledgment which was to be FAX-Back indicating that the information was received and understood. Agfa has discussed with the customer how the de-installation of their CRS Remote product - Software Version 7.8_HL would be performed. |
| Quantity | One |
| Distribution | TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |