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FDA-Device2026-03-11Class IIPROCESSING DEFECT

Olympus ShockPulse-SE Lithotripsy System recalled for generator recognition failure

Olympus
OTHERNationwide distribution

Contact Olympus about ShockPulse-SE device issues

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
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
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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