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Health Canada Medical devices

Solea

Issued September 20, 2023
Issue
In normal use, the laser is activated when the user sets the device to the "armed" state and when the foot pedal is depressed in the "armed" state. (the laser is deactivated when it is not in the armed state). However, there were reported events where the laser was activated in the armed state when the user did not actively depress the foot pedal. Recall start date: August 24, 2023
Hazard description
Performance
Product
Product name
Solea
Reference
ID
RA-74308