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Health Canada Medical devices

Alphenix INFX-8000v - Main Unit

Issued November 8, 2023
Issue
It has been found that due to problems with the internal board of x-ray flat panel detector configured in the x-ray interventional systems, abnormal images such as horizontal stripes may be displayed and recovery probably could not be possible by restarting the system. Recall start date: October 23, 2023
Hazard description
Performance
Product
Product name
Alphenix INFX-8000v - Main Unit
Reference
ID
RA-74565