Z-1714-2014Class II

Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic...

Name: Z-1714-2014 Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic...
Creator: Toshiba American Medical Systems Inc
Published: 2014-05-12
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2014-05-12 / Terminated

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional... on 2014-05-12. FDA classified it as Class II and gives the reason as "Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1714-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-12
Posted: 2014-06-04
Terminated: 2014-10-02
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.
FDA root cause: Other
Action: Toshiba America Medical Systems, Inc. initiated this recall by sending recall notifications via USPS return receipt mail. The recall notification letter, dated May 12, 2014, titled "URGENT: MEDICAL DEVICE CORRECTION", informed customers of the following: device information, serial number, SID, reason for reason, purpose of the notification, corrective action, request to customers, contact information, and customer reply form. Customers with questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968. For questions regarding this recall call 714-730-5000.
Quantity in commerce: 2
Distribution: Nationwide Distribution including CA and IN
Product codes and lots: Serial Numbers: ULD1412014, UUC13Z2011, A4A113Z2001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1714-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1714-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-04

Product code MQB

K120073Class IIInfx-8000V withToshibamedical Systems Corporation / cleared 2012-01-26

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)