SOLTIVE™ Premium SuperPulsed Laser System

Olympus received a complaint regarding the SOLTIVE™ Laser System preset laser settings. The term "bladder stone" was incorrectly translated in both Spanish and Portuguese to "kidney stone" (cálculo renal) on the systems' graphical user interface (GUI). As a result of the incorrect Spanish and Portuguese translation from "bladder stone" to "kidney stone" on the GUI, there is a potential to deliver an incorrect or unintended amount of energy to the patient's anatomy. This issue is specific to the preset laser settings and does not affect users who are not utilizing the preset option.

Recall start date: September 12, 2024