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

Class I - Dangerous

🏥 Medical Devices Recalled: June 30, 2021 Olympus Corporation of the Americas Infusion Pumps Nationwide

What Should You Do?

Check if you have this product:
Software Version 2.0 (all serial numbers)
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Olympus Corporation of the Americas
Reason for Recall:: Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full 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