Olympus recalls SOLTIVE Premium Laser Systems with TFL-PLS model containing TFL-CPLU component due to potential 24V power supply defect causing system inoperability or smoke/burning smell. Self-extinguishing if smoke occurs.
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Olympus is recalling some SOLTIVE Premium Laser Systems (TFL-PLS model with TFL-CPLU component) because a potential defect in the 24V power supply may cause the system to stop working or produce smoke/burning smells. The smoke would be contained within the device and self-extinguish.
A potential defect in the 24V power supply module may cause the laser system to become inoperable. Additionally, smoke or a burning smell could occur, though the issue would be contained within the device and self-extinguish.
Users of the Olympus SOLTIVE Premium Laser System (TFL-PLS model) with specific serial numbers listed in the recall. Medical professionals using the device for tissue ablation are most at risk.
Check for the SOLTIVE Premium Laser System TFL-PLS model with TFL-CPLU component. The device has specific serial numbers listed in the recall (e.g., MDUF220005, MDUF220005, etc.).
Compare your device's serial number to the list of affected units provided in the recall notice.
The recall indicates a potential defect that could cause the system to become inoperable or produce smoke/burning smell, but the smoke would be self-extinguishing and contained within the device.
Check if your device has the SOLTIVE Premium Laser System TFL-PLS model with TFL-CPLU component and a serial number listed in the recall (e.g., MDUF220005, MDUF220005, etc.).
No action is required if your device's serial number is not listed in the recall notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1694-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1694-2026 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.
