Olympus Corporation of the Americas: Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTI

Hazard

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

Details from the source

Reason for recall: Preset treatment parameters are not consistently being used in accordance with the IFU. Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK. Quantity: 189 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

UPC codes

00821925044135, 00821925044111, 00821925044586, 00821925044593

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.