medical Class II Updated 2024-10-30

Olympus Corporation of the Americas recalls Soltive Pro SuperPulsed Laser Systems-Intended for incision,

Recalled Product

Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI 00821925044135 All Serial Numbers
View official government recall

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