Canon Medical System, USA, INC. INFX-8000V. For radiographic and fluoroscopic studies and intervention. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Brand
Canon Medical System, USA, INC.
Lot Codes / Batch Numbers
Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.
Products Sold
Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.
Canon Medical System, USA, INC. is recalling INFX-8000V. For radiographic and fluoroscopic studies and intervention. due to The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026