Z-0325-06

Digital Radiography System Model DFP-8000D/FPD

Name: Z-0325-06 Digital Radiography System Model DFP-8000D/FPD
Creator: Toshiba American Med Sys Inc
Published: 2005-11-10
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2005-11-10 / Terminated / root cause: software

FDA source

Toshiba American Med Sys Inc began a recall of Digital Radiography System Model DFP-8000D/FPD on 2005-11-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0325-06
Status: Terminated
Initiated: 2005-11-10
Posted: 2005-12-23
Terminated: 2007-02-05
Recalling firm: Canon Medical Systems USA, Inc.
Product: Digital Radiography System Model DFP-8000D/FPD,
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
Root cause tag: software
FDA 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 in commerce: 13
Distribution: Nationwide
Product codes and lots: Serial Numbers: B5522165 B4592121 B4602124 B4602126 W1B0542172 W1B0542174 B4582115 B4622147 B4572111 B5522161 B5512160 A4562105 B4582113

Product code JAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)