Home / Recalls / Olympus Corporation of the Americas / Z-2294-2021

Z-2294-2021 Class II Terminated

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
August 25, 2021
Initiation Date
June 30, 2021
Termination Date
January 26, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
408 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore

Code Information

Software Version 2.0 (all serial numbers)

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