FDA-Device2021-03-17Class II
System INFX-8000V
Canon Medical System, USA, INC.
Hazard
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Sold states
Nationwide
Affected count
272 in total
Manufactured in
2441 Michelle Dr, Tustin, CA, United States
Products
System INFX-8000V
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1174-2021Don't want to check this manually?
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