Z-1666-2022 Class II Ongoing
FDA device recall Z-1666-2022 was initiated by Canon Medical System, USA, INC. on January 31, 2022 and is designated Class II. Reason for recall: The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy. The recall status is ongoing. Affected quantity: 16 systems.
Recall Details
- Product Type
- Devices
- Report Date
- September 7, 2022
- Initiation Date
- January 31, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 16 systems
Product Description
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Reason for Recall
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Distribution Pattern
US Nationwide Distribution
Code Information
Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.