Health Canada — Medical Devices · Canada · 2025-05-28 · Type II
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Reported risk: During clinical use, thermal incidents have the potential to occur while using the Soltive Laser Systems and fibers when laser energy is unintentionally redirected and scattered out of the laser fiber core through a fracture in the fiber. Users should carefully follow the instructions for use of the affected devices. Recall start date: May 15, 2025
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