Olympus recalls Soltive Premium SuperPulsed Laser due to incorrect Spanish/Portuguese translation of 'Bladder Stone' as 'Kidney Stone' on the GUI, potentially causing 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.
Olymp: Olympus is recalling its Soltive Premium SuperPulsed Laser devices because the software incorrectly translates 'Bladder Stone' as 'Kidney Stone' in Spanish and Portuguese. This could lead to delivering the wrong amount of energy during medical procedures, risking patient harm.
The device's Graphical User Interface (GUI) incorrectly translates 'Bladder Stone' as 'Kidney Stone' in Spanish and Portuguese. This could cause the medical team to use the device for the wrong type of procedure, potentially delivering an incorrect amount of energy to the patient's anatomy.
Medical professionals using the Soltive Premium SuperPulsed Laser for surgical procedures are affected. Patients undergoing procedures with this device may be at risk if the incorrect translation leads to improper energy delivery.
Check for the model TFL-PLS with serial numbers listed in the recall notice. The device is intended for surgical procedures involving soft tissue removal.
Verify the model number is TFL-PLS and the serial number matches the list provided in the recall notice.
The device's Graphical User Interface incorrectly translates 'Bladder Stone' as 'Kidney Stone' in Spanish and Portuguese, which could lead to delivering an incorrect amount of energy during procedures.
Check the model number and serial number to confirm if your device is affected. The recall notice does not specify a remedy for affected devices.
The recall states a potential risk of incorrect energy delivery, but the official notice does not specify that serious injury is likely.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0134-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0134-2025 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.
