Z-1337-04

Digital Radiography System, model DFP-8000D

Name: Z-1337-04 Digital Radiography System, model DFP-8000D
Creator: Toshiba American Med Sys Inc
Published: 2004-06-18
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2004-06-18 / Terminated

FDA source

Toshiba American Med Sys Inc began a recall of Digital Radiography System, model DFP-8000D on 2004-06-18. The reason FDA records is "Defect in the mirroring unit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1337-04
Status: Terminated
Initiated: 2004-06-18
Posted: 2004-08-11
Terminated: 2005-03-15
Recalling firm: Canon Medical Systems USA, Inc.
Product: Digital Radiography System, model DFP-8000D
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Defect in the mirroring unit.
FDA root cause: Other
Action: An advisory letter will be sent to all users 6/24/2004. An order was issued to correct the firmware problem.
Quantity in commerce: 19
Distribution: Nationwide.
Product codes and lots: All codes

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)