Recall Z-0993-04 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Fujifilm Medical System USA, Inc.
Fuji Flash IIP and CR-IR346CL Consoles
| Date | Jul 20, 2004 (initiated May 5, 2004) |
| Status | Terminated |
| Reason | Software: Incorrect measurement of objects within a CR image |
| Root cause | Other |
| Action | FujiFilm Medical Systems issued notification letter dated 5/5/04 via Certified Mail. Units will be field corrected with a revised software by a service representative. |
| Quantity | 2602 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013218 | FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II Fujifilm Medical System U.S.A., Inc., Dec 20, 2001 |