Olympus Corporation of the Americas: Brand Name: ShockPulse-SE Lithotripsy System Product

Olympus Corporation of the Americas: Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Produ

Medical DevicesSource: FDA (device) · Date: 2026-03-11

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Olympus Corporation of the Americas
Product: Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Reason / hazard: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Classification: Class II
Status: Ongoing
Distribution / sold at: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
Recall initiated: 2025-11-14
Code info: Model/Catalog Number: SPL-G; UDI: 00821925044203; Serial Numbers: All;
Product quantity: 1684 units
Voluntary mandated: Voluntary: Firm initiated
City: Center Valley
State: PA
Country: United States
Event id: 98359