FDA-Device2022-09-07Class II
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Canon Medical System, USA, INC.
Hazard
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Sold states
US Nationwide Distribution
Affected count
16 systems
Manufactured in
2441 Michelle Dr, Tustin, CA, United States
Products
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1666-2022Don't want to check this manually?
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