Recall Z-1256-06 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images.
| Date | Jul 27, 2006 (initiated Jun 30, 2006) |
| Status | Terminated |
| Reason | Possible corrupted image appearing after System Start. |
| Root cause | Other |
| Action | On 06/30/2006 Agfa upgraded the Software on the installed units using a Mandatory Service Bulletin DD+DIS225.06E. |
| Quantity | 2 units |
| Distribution | NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022292 | IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO Agfa Corp., Sep 12, 2002 |