Recall Z-2294-2021— Olympus Corporation of the Americas
Class II · Terminated
Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2021-06-30, terminated 2024-01-26. It names one FDA 510(k) clearance: K211401. 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. Reason: Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets.
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-30
- Terminated
- 2024-01-26
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.