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
Reported: May 7, 2025 Initiated: April 4, 2025 #Z-1715-2025
Product Description
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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 189
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Olympus Corporation of the Americas. Units affected: 189.
Why was this product recalled? ▼
Preset treatment parameters are not consistently being used in accordance with the IFU.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 7, 2025. Severity: Moderate. Recall number: Z-1715-2025.
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