Digital Radiography System Model DFP-8000D/FPD,
FDA device recall Z-0325-06 · posted 2005-12-23 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 13
- Distribution
- Nationwide
- Date initiated
- 2005-11-10
- Date posted
- 2005-12-23
- Date terminated
- 2007-02-05
- Location
- Tustin, CA
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