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FDA-Device2026-03-11Class IIPROCESSING DEFECT

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

Olympus
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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