FDA-Device2026-04-08Class IIPROCESSING DEFECT

Olympus SOLTIVE Premium laser system recalled for defective power supply

ELECTRICAL SHOCKFIRENationwide distribution

Stop using affected Olympus SOLTIVE laser systems

Olympus identified a defect in the 24V power supply module in some SOLTIVE Premium 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 internal enclosure where it will self-extinguish.

  • Check if your Olympus SOLTIVE laser system serial number matches the affected list
  • Stop using the device immediately if your serial number is listed
  • Contact Olympus Corporation of the Americas for instructions on repair or replacement
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
408 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU 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-1694-2026

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