FDA Medical Device Recalls (openFDA)
Toshiba American Med Sys Inc: Digital Radiography System Model DFP-8000D/FPD
- Recall number
- Z-0325-06
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- Digital Radiography System Model DFP-8000D/FPD,
- Status
- Terminated
- Initiated
- 2005-11-10
- Posted
- 2005-12-23
- Terminated
- 2007-02-05
- 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
- Lot, serial or model codes
- Serial Numbers: B5522165 B4592121 B4602124 B4602126 W1B0542172 W1B0542174 B4582115 B4622147 B4572111 B5522161 B5512160 A4562105 B4582113
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28