Z-0532-06

Toshiba Digital Radiography System Model DFP8000D

Name: Z-0532-06 Toshiba Digital Radiography System Model DFP8000D
Creator: Toshiba American Med Sys Inc
Published: 2005-11-15
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2005-11-15 / Terminated

FDA source

Toshiba American Med Sys Inc began a recall of Toshiba Digital Radiography System Model DFP8000D on 2005-11-15. The reason FDA records is "In certain conditions the FOV of the lateral plane does not coincide with the X-ray exposed area, and consequently a part of the X-ray field may not be displayed in the magnification mode". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0532-06
Status: Terminated
Initiated: 2005-11-15
Posted: 2006-02-23
Terminated: 2007-07-12
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba Digital Radiography System Model DFP8000D
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: In certain conditions the FOV of the lateral plane does not coincide with the X-ray exposed area, and consequently a part of the X-ray field may not be displayed in the magnification mode.
FDA root cause: Other
Action: An Advisory Letter will be sent to customers via certified mail. Corrected software will be provided at no charge. Customers can contact their local Toshiba Service person to schedule the software update.
Quantity in commerce: 3
Distribution: CO, MI, & TX
Product codes and lots: Serial #s W1C0552175, W1C0552181, W1C0562189

Product code JAA

K013608Class IIDigital Radiography System, Model Dfp-8000DToshiba America Medical Systems, In.C / cleared 2001-11-15

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)