FDA Enforcement
Class II
Ongoing
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Recall: Z-1666-2022
·
Reported September 7, 2022
Enforcement
- Recall Number
- Z-1666-2022
- Event ID
- 90737
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Canon Medical System, USA, INC.
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- September 7, 2022
- Initiation Date
- January 31, 2022
- Classification Date
- September 1, 2022
- Address
- 2441 Michelle Dr, Tustin, CA, 92780-7047, United States
Description
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Reason
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Code Info
Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.
Distribution
US Nationwide Distribution
Quantity
16 systems