Z-0452-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 19, 2025
- Initiation Date
- October 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1528 units
Product Description
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T 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. Component: ShockPulse Lithotripsy System
Reason for Recall
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.
Code Information
Model/Catalog Number: SPL-T; UDI-PI: 00855279005023; All serial numbers;