Olympus recalls Soltive Premium and Pro Super Pulsed Laser Systems due to risk of thermal injury when treating ureteral stones with settings exceeding 20W. Affected units have Software Version 2.0 and specific serial numbers.
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
Olympus is recalling two laser systems used in urology for stone treatment because using them with settings higher than 20W can cause thermal injury. This risk occurs when the device is used on ureteral stones and the user exceeds the safe power limits.
The laser systems can cause thermal injury if the user sets the power level above 20W when treating ureteral stones. This happens because the device's dusting and fragmenting treatment process for stones may overheat, leading to tissue damage.
Urology surgeons and medical professionals who use the Soltive Premium Super Pulsed Laser System (TFL-PLS) or Pro Super Pulsed Laser System (TFL-SLS) with Software Version 2.0 are most at risk. These devices are used for procedures involving ureteral stones.
Check for the Soltive Premium Super Pulsed Laser System (TFL-PLS) or Pro Super Pulsed Laser System (TFL-SLS) with Software Version 2.0. These devices were sold for urological procedures and are used in hospitals and clinics.
Verify that the laser power setting does not exceed 20W when treating ureteral stones.
The hazard is thermal injury from using the laser at power levels above 20W when treating ureteral stones, which can cause tissue damage.
No, but you must ensure power settings do not exceed 20W when treating ureteral stones to avoid thermal injury.
Software Version 2.0 is affected; all units with this version are included in the recall.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2294-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2294-2021 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.
