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FDA-Device2026-04-08Class IIPROCESSING DEFECT

Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect

Olympus
ELECTRICAL SHOCKFIRENationwide distribution

Stop using affected Olympus SOLTIVE Pro laser units

Olympus identified a defect in the 24V power supply module in some SOLTIVE Pro laser systems that may cause the device to stop working. In some cases, smoke or a burning smell may occur inside the laser console, though the design contains any smoke within the enclosure where it will self-extinguish.

  • Check if your SOLTIVE Pro laser system serial number matches the affected list provided by Olympus
  • Stop using the device immediately if your unit is on the recall list
  • Contact Olympus for instructions on repair or replacement of the power supply module
Hazard

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.

Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.
Affected count
32 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1695-2026

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