Z-0005-2009

Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software...

Name: Z-0005-2009 Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software...
Creator: Toshiba American Medical Systems Inc
Published: 2008-09-29
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2008-09-29 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems on 2008-09-29. The reason FDA records is "Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation". 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-0005-2009
Status: Terminated
Initiated: 2008-09-29
Posted: 2009-09-28
Terminated: 2012-10-04
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation.
Root cause tag: software
FDA root cause: Software design
Action: Toshiba issued a letter entitled Important Electronic Product Radiation Warning, September 30, 2008, explaining the issue. The customers were requested to reply to the letter via fax-back form, and a Toshiba service representative would install the corrective action.
Quantity in commerce: 129
Distribution: Nationwide
Product codes and lots: Software version 3.40 or higher

Product code MQB

K081624Class IIInfx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C / cleared 2008-06-23

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)