—#216278

Product

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

FDA product code: FEO — Lithotriptor, Ultrasonic
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K171024
Affected lot / code info: Model/Catalog Number: SPL-T; UDI-PI: 00855279005023; All serial numbers;

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

On October 8, 2025 URGENT: MEDICAL DEVICE ADVISORY NOTICE letters were sent to customers. Actions to be taken: Ensure you read the content of the notice. Ensure that all personnel are aware and knowledgeable on the content of the notice. You may continue to use the device according to the instruction for use, which cautions users to ensure that a back-up transducer and probe are sterilized and available prior to beginning a procedure. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you acknowledge receipt of this letter with the provided reply form.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.

Timeline

Recall initiated: 2025-10-08
Posted by FDA: 2025-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216278. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.