Z-0324-06

Digital Radiography System Model DFP8000D

Name: Z-0324-06 Digital Radiography System Model DFP8000D
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 DFP8000D 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-0324-06
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 DFP8000D
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: 72
Distribution: Nationwide
Product codes and lots: Serial Numbers: A3622068 A4512074 A3582042 A3542012 A4512073 A3552017 A4552098 A3622065 A3622066 A4542090 A3592048 B4602125 B4612134 B5512155 B4582116 W1B0542168 A3572018 A4562102 A35B2041 B4612132 A3542011 A3582037 A3622069 B4622149 B4602129 A3542006 B4612133 A3572032 A3522002 B4622146 A3542008 A3602050 A4512076 A4522079 A4522081 B4622150 B5522162 A3592046 A3532005 A3612057 A4572109 A3517002 B4622148 A4562099 A3612061 A4562101 B4612137 A3602055 A4542092 B5512154 A4542088 A3572030 A3582035 A3522004 A3562022 A3582036 B4622151 A3582013 A3582013 A45721 07 B4612141 A3517003 A4522080 A3522001 W180542173

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)