Olymp: Soltive Pro SuperPulsed Laser Systems may display 'Kidney Stone' instead of 'Bladder Stone' in Spanish/Portuguese, risking incorrect energy delivery during procedures.
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.
Olympus is recalling Soltive Pro SuperPulsed Laser Systems due to a translation error in the software that could lead to incorrect medical procedures. This risk affects patients receiving laser treatments for urinary tract issues.
The system's interface incorrectly translates 'Bladder Stone' as 'Kidney Stone' in Spanish and Portuguese. This could cause doctors to target the wrong area during surgery, potentially leading to incorrect tissue damage.
Medical professionals using the Soltive Pro systems for urinary procedures in the U.S. are most at risk if they misinterpret the software labels.
Check for the model TFL-SLS with serial numbers listed in the recall notice. The system is sold in the U.S. and used for urinary procedures.
Check the system's interface for Spanish or Portuguese language settings to identify the translation error.
The recall is for medical devices used by professionals, not patients directly.
Look for the model TFL-SLS with serial numbers listed in the recall notice.
Review the software labels for Spanish or Portuguese settings to confirm the error.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0135-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0135-2025 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
