Z-1666-2022Class II

INFX-8000V. For radiographic and fluoroscopic studies and intervention

Name: Z-1666-2022 INFX-8000V. For radiographic and fluoroscopic studies and intervention
Creator: Canon Medical System, USA, INC.
Published: 2022-01-31
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2022-01-31 / Open, Classified / root cause: software

FDA source

Canon Medical System, USA, INC. began a recall of INFX-8000V. For radiographic and fluoroscopic studies and intervention on 2022-01-31. FDA classified it as Class II and gives the reason as "The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1666-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-31
Posted: 2022-09-02
Recalling firm: Canon Medical Systems USA, Inc.
Product: INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Root cause tag: software
FDA root cause: Software design
Action: Canon sent an Urgent Electronic Product Radiation Warning letter dated July 28, 2022 to customers. . Customer were informed that in the interim a temporary countermeasure will be performed until such time as the software becomes available. A representative of Canon Medical Systems USA will contact you to schedule a time to install the countermeasure and at a later date, the updated software to address the issue. For scheduling questions, please contact our InTouch team at [email protected]. For questions call 800-421-1968 or your Canon service representative at 800.521.1968.
Quantity in commerce: 16 systems
Distribution: US Nationwide Distribution
Product codes and lots: Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1666-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1666-2022	Class II	Ongoing	FDA Mandated	2022-09-07	2022-09-01

Product code OWB

K170909Class IIInfinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation / cleared 2017-06-16

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)