Z-1921-2025 Class II Ongoing
FDA device recall Z-1921-2025 was initiated by Olympus Corporation of the Americas on May 6, 2025 and is designated Class II. Reason for recall: Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, the… The recall status is ongoing. Affected quantity: 1549 units (1025 US, 524 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2025
- Initiation Date
- May 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1549 units (1025 US, 524 OUS)
Product Description
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: N/A
Reason for Recall
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Code Information
All lot/serial numbers for the following products: TFL-PLS UDI: 00821925044111; TFL-PLS-JA (Japan only);