INFX-8000V. For radiographic and fluoroscopic studies and intervention.
- Company
- Canon Medical System, Usa, Inc.
- Recall Initiated
- January 31, 2022
- Recall Number
- Z-1666-2022
- Quantity
- 16 systems
- Firm Location
- Tustin, CA
Reason for Recall
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Distribution
US Nationwide Distribution
Lot / Code Info
Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.
Root Cause
Software design
Action Taken
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 intouchdispatch@us.medical.canon. For questions call 800-421-1968 or your Canon service representative at 800.521.1968.