INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Recall
- Recall Number
- Z-1666-2022
- Event Number
- 90737
- Firm
- Canon Medical System, USA, INC.
- FEI Number
- 2020563
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- January 31, 2022
- Address
- 2441 Michelle Dr, Tustin, CA, 92780-7047
Description
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
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.
US Nationwide Distribution
16 systems