Recall Z-0532-06 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Toshiba American Med Sys Inc
Toshiba Digital Radiography System Model DFP8000D
| Date | Feb 23, 2006 (initiated Nov 15, 2005) |
| Status | Terminated |
| Reason | In certain conditions the FOV of the lateral plane does not coincide with the X-ray exposed area, and consequently a part of the X-ray field may not be displayed in the magnification mode. |
| Root cause | Other |
| Action | An Advisory Letter will be sent to customers via certified mail. Corrected software will be provided at no charge. Customers can contact their local Toshiba Service person to schedule the software update. |
| Quantity | 3 |
| Distribution | CO, MI, & TX |
| 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 |