medical Class II Updated 2021-08-25

Olympus Corporation of the Americas recalls Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Su

Recalled Product

Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery

Hazard / Issue

Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software Version 2.0 (all serial numbers)
View official government recall

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