[pending] Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System M
Pending LLM rewrite. Source: FDA_DEVICE Z-1715-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Preset treatment parameters are not consistently being used in accordance with the IFU.
The recalled product
- 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 poten
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- SOLTIVE Pro SuperPulsed Laser System: UDI-DI: TFL-SLS - 00821925044135
- TFL Standard Laser Unit UDI-DI: TFL-CPLU - 00821925044586
- TFL-CSLU - 00821925044593
Distribution
Distributed nationwide across the United States.
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