Recall Z-0325-06 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Toshiba American Med Sys Inc
Digital Radiography System Model DFP-8000D/FPD,
| Date | Dec 23, 2005 (initiated Nov 10, 2005) |
| Status | Terminated |
| Reason | To correct a software problem that caused the LV images, which were acquired for 15 seconds at the end of the examination, to be lost. |
| Root cause | Other |
| Action | An Advisory Letter was sent to the customers via certified mail. Toshiba issued a Field Modification Instruction (FMI XRA29-90828) to correct that software bug and bring the DFP-8000D into compliance. The FMI is provided to the customers at no charge. |
| Quantity | 13 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.