Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS

Reason: 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.

Code information: UDI 00821925044111 All Serial Numbers:

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