Recall Z-0855-06 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
AGFA Corp.
CR DX-S, DX-S, Computed radiography system (Digitizer)
| Date | May 9, 2006 (initiated Nov 3, 2005) |
| Status | Terminated |
| Reason | Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop. |
| Root cause | Other |
| Action | Consignees were notified at the time of upgrading. The software was upgraded on 11/3/2005, 12/19/2005 and 12/28/2005. A Mandatory Service Bulletin, No. 11, explaining the issues was shared with the accounts. |
| Quantity | 3 units |
| Distribution | DC, MS, OR--three states |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050810 | AGFA CR50.0 Agfa Corp., Apr 21, 2005 |