FDA-Device2026-03-11Class IIPROCESSING DEFECT

Olympus ShockPulse-SE Lithotripsy System recalled for generator recognition failure

OTHERNationwide distributionMedical devices

What this means

The Olympus ShockPulse-SE Lithotripsy System, used to break up kidney stones and similar calculi, may experience problems where the generator remains in a blinking phase and fails to recognize the transducer. This can happen if the transducer plug or generator receptacle becomes damaged. No injuries have been reported.

If you use this device in a clinical setting, contact Olympus Corporation of the Americas for guidance on your specific unit
Do not use the device if the generator blinks and does not recognize the transducer
Check the transducer plug and generator receptacle for any visible damage

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

1082 units

Manufactured in

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

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1478-2026

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