FDA recall Z-1715-2025

Olympus Corporation of the Americas · Class II · device

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

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.

Key facts

Status: Ongoing
Initiation date: 2025-04-04
Report date: 2025-05-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1715-2025