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FDAAugust 13, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925044135

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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