Reported Aug 25, 2021 · Terminated
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision,…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-0610
Is this the product you have?
- 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
- Lot codes and dates
- Software Version 2.0 (all serial numbers)
- Amount recalled
- 408 units
Where it was sold
- Nationwide
Why it was recalled
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
This product could cause temporary or reversible health problems — stop using it.
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