BEUDAMED
    FDA Recall Open, Classified

    Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S 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.

    Recall: Z-1478-2026 · Initiated November 14, 2025

    Recall

    Recall Number
    Z-1478-2026
    Event Number
    98359
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FEO
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    November 14, 2025
    Posted
    February 27, 2026
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S 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

    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.

    Action

    On or about December 18, 2025 URGENT: MEDICAL DEVICE CORRECTION - UPDATE letters were sent to customers. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the new Supplemental Guidance. Add a copy of this letter with the Supplemental Guidance to your existing Instruction for Use. You may continue to use the device according to this letter and 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 and forward this notification to them.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.

    Quantity

    1082 units