Class II

Medical Device Recall: Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS

Olympus Corporation of the Americas · August 13, 2024

Reason for Recall

The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.

Distribution

Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.

States Affected

NATIONWIDE

Quantity Affected

159 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0135-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.