FDA-Device2024-10-30Class II
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Olympus Corporation of the Americas
Hazard
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Sold states
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Affected count
159 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0135-2025Don't want to check this manually?
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