FDA-Device2026-02-04Class II
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Canon Medical System, USA, INC.
Hazard
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Sold states
Worldwide distribution - US Nationwide and the country of Dominican Republic.
Affected count
172 units
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1176-2026Don't want to check this manually?
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