FDA-Device2026-03-11Class IIPROCESSING DEFECT

Olympus ShockPulse-SE Lithotripsy System recalled for device recognition failure

OTHERNationwide distributionMedical devices

What this means

Olympus Corporation is recalling ShockPulse-SE Lithotripsy Systems (Model SPL-SR) because the generator may get stuck in a blinking state and fail to recognize the reusable probe. This can happen if the probe plug or generator connection becomes damaged. The device is used in hospitals and medical facilities to break up kidney stones and similar calculi.

Stop using affected units immediately if you have one.
Contact Olympus Corporation for inspection, repair, or replacement of your device.
Check your device serial number against recall notices—all serial numbers are affected.

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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

Affected count

602 units

Manufactured in

3500 Corporate Pkwy, N/A, Center Valley, PA, United States

Products

Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1477-2026

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