Z-0100-04

Digital Fluorographic System model DFP-2000A

Name: Z-0100-04 Digital Fluorographic System model DFP-2000A
Creator: Toshiba American Med Sys Inc
Published: 2003-05-27
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2003-05-27 / Terminated

FDA source

Toshiba American Med Sys Inc began a recall of Digital Fluorographic System model DFP-2000A on 2003-05-27. The reason FDA records is "Images display with wrong patient demographics". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0100-04
Status: Terminated
Initiated: 2003-05-27
Posted: 2003-11-06
Terminated: 2005-03-15
Recalling firm: Canon Medical Systems USA, Inc.
Product: Digital Fluorographic System model DFP-2000A.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Images display with wrong patient demographics.
FDA root cause: Other
Action: Firm has issued to it''s service persons orders to install a software fix on 27 May 2003.
Quantity in commerce: 471
Distribution: Naitonwide.
Product codes and lots: All serial numbers, all codes.

Product code JAA

K941611Class IITda-4000/A4Toshiba America Medical Systems, In.C / cleared 1994-05-13

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)