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Olympus Corporation of the Americas recalls Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, ex
Recalled August 25, 2021 · FDA recall Z-2294-2021 · Olympus Corporation of the Americas
Hazard
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets · FDA Class II
Units
408 units
Sold at
US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore
Description
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
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
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →