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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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.
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