ANSM Safety Alert for Soltive SuperPulsed Laser Systems

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert (R2607992) concerning Soltive SuperPulsed laser systems. This alert is based on a security action implemented by the manufacturer, Olympus, and users have been directly informed via correspondence from the company. The alert is intended for pharmacies within healthcare facilities and distributors.

Healthcare providers and distributors using these laser systems should review the safety information provided by Olympus, which was attached to the ANSM notification. While this is a safety alert and not a regulatory mandate with explicit penalties, failure to address potential safety concerns could lead to patient harm and reputational damage. Compliance officers should ensure their facilities have received and acted upon the manufacturer's specific guidance.