Z-1666-2022 Class II Ongoing
FDA device recall Z-1666-2022 was initiated by Canon Medical System, USA, INC. on Jan 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
- Sep 7, 2022
- Initiation Date
- Jan 31, 2022
- 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1666-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026