FDA recall Z-1666-2022
Canon Medical System, USA, INC. · Class II · device
Product
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
US Nationwide Distribution
Key facts
- Status
- Ongoing
- Initiation date
- 2022-01-31
- Report date
- 2022-09-07
- Voluntary/Mandated
- FDA Mandated
- Location
- Tustin, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1666-2022