FDA Enforcement
Class II
Terminated
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
Recall: Z-2294-2021
·
Reported August 25, 2021
Enforcement
- Recall Number
- Z-2294-2021
- Event ID
- 88229
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 25, 2021
- Initiation Date
- June 30, 2021
- Classification Date
- August 15, 2021
- Termination Date
- January 26, 2024
- Address
- 3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States
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
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
Code Info
Software Version 2.0 (all serial numbers)
Distribution
US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore
Quantity
408 units