Z-2294-2021 Class II Terminated
FDA device recall Z-2294-2021 was initiated by Olympus Corporation of the Americas on June 30, 2021 and is designated Class II. Reason for recall: Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets The recall status is terminated (terminated January 26, 2024). Affected quantity: 408 units.
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)