Z-0293-2008

Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography...

Name: Z-0293-2008 Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography...
Creator: Toshiba American Med Sys Inc
Published: 2007-10-01
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2007-10-01 / Terminated / root cause: software

FDA source

Toshiba American Med Sys Inc began a recall of Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Software version 3.4er000, Toshiba America... on 2007-10-01. The reason FDA records is "System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error". 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-0293-2008
Status: Terminated
Initiated: 2007-10-01
Posted: 2007-11-27
Terminated: 2012-04-05
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Software version 3.4er000, Toshiba America Medical Systems, Inc., Tustine, CA 92780
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.
Root cause tag: software
FDA root cause: Software design
Action: Notification letters (Urgent: Medical Device Correction-dated October 1, 2007) with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found done by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.
Quantity in commerce: 23
Distribution: Nationwide-including states of AL, AR, FL, GA, MI, NY, OH, PA, TX & WV
Product codes and lots: Serial numbers: B5522165, W1C0562187, W1C0572197, W1C0572202, W1C0622275, W1C0622270, A3632065, A3622066, W1C0456192, W1C0632284, W1D0722373, W1D0742386, B5512160, W1C0592213, W1C0592215, A4562099, W1C05Z2254, B4582113, W1C0642289, W1D0697015, W1C0552182, W1C05X2224, W1D0742387

Product code MQB

K052884Class IIModel Dfp-8000D/fpd Digital Radiography System with Flat Panel DetectorToshiba America Medical Systems, In.C / cleared 2005-10-26

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)