Recall Z-1337-04 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Toshiba American Med Sys Inc
Digital Radiography System, model DFP-8000D
| Date | Aug 11, 2004 (initiated Jun 18, 2004) |
| Status | Terminated |
| Reason | Defect in the mirroring unit. |
| Root cause | Other |
| Action | An advisory letter will be sent to all users 6/24/2004. An order was issued to correct the firmware problem. |
| Quantity | 19 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013608 | DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D Toshiba America Medical Systems, In.C, Nov 15, 2001 |