FDA-Device2026-03-11Class IIPROCESSING DEFECT

Olympus ShockPulse-SE Lithotripsy System generator recalled for connection recognition failure

OTHERNationwide distribution

Stop using Olympus ShockPulse-SE lithotripsy generators

The Olympus ShockPulse-SE Lithotripsy System generator (model SPL-G) may fail to recognize its transducer and remain in a blinking waiting state. This can happen if the transducer plug or generator receptacle becomes damaged. The device is used in medical settings to break up kidney stones and similar calculi.

Stop using affected ShockPulse-SE generators (model SPL-G, all serial numbers)
Check your device for any visible damage to the transducer plug or generator receptacle
Contact Olympus Corporation of the Americas for repair or replacement instructions
Do not attempt to use the device if it remains in a blinking state or fails to recognize the transducer

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.

Sold states

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

Affected count

1684 units

Manufactured in

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

Products

Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G 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-1479-2026

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