medical Class II Updated 2025-05-07

Olympus Corporation of the Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name:

Recalled Product

Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No

Hazard / Issue

Preset treatment parameters are not consistently being used in accordance with the IFU.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: SOLTIVE Pro SuperPulsed Laser System: UDI-DI: TFL-SLS - 00821925044135; TFL-PLS - 00821925044111 All units included Powered Laser Surgical Instrument - Laser module component information Name: TFL Premium Laser Unit, TFL Standard Laser Unit UDI-DI: TFL-CPLU - 00821925044586; TFL-CSLU - 00821925044593
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