Alphenix INFX-8000C, interventional fluoroscopic x-ray system
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
Worldwide distribution - US Nationwide and the country of Dominican Republic.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1176-2026