Official recall record

SOLTIVE™ Premium SuperPulsed Laser System

Health Canada — Medical Devices · 2024-09-25 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2024-09-25
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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