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Health Canada Medical devices

FDR Visionary Suite

Issued March 5, 2026
Issue
Potential safety issue with the X-ray high voltage generator incorporated into the FDR Visionary Suite X-ray diagnostic equipment. It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator may weld, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it is possible that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
Hazard description
Performance
Product
Product name
FDR Visionary Suite
Reference
ID
RA-81686