The Recall Desk
HighFDA (Devices)·Z-0135-2025·Announced 2024-10-30

Olympus Soltive Pro Laser Systems Recalled for Incorrect Bladder Stone Translation

Olympus is recalling Soltive Pro SuperPulsed Laser Systems because the term 'Bladder Stone' was incorrectly translated as 'Kidney Stone' in Spanish and Portuguese, posing a risk of unintended energy delivery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a software error could lead to unintended energy delivery to patient anatomy, representing a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Olympus Corporation of the Americas is recalling 159 units of the Soltive Pro SuperPulsed Laser Systems (Model TFL-SLS). The recall is due to a software error where the term 'Bladder Stone' was incorrectly translated as 'Kidney Stone' (Cálculo renal) in the Spanish and Portuguese versions of the system's Graphical User Interface (GUI).

This translation error creates a potential risk that the system may deliver an incorrect or unintended amount of energy to the patient's anatomy. The affected devices were distributed worldwide, including in the United States, Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore.

Healthcare providers and users of these laser systems should stop using the affected units and contact Olympus Corporation of the Americas for further instructions on the recall and corrective actions.

The recalled product

Product
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Laser Systems
Hazard
Affected units
159

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI 00821925044135 All Serial Numbers

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Olympus Corporation of the Americas

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Same hazard · software error

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