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Moderate riskFDA DeviceClass II

Olympus ShockPulse-SE Lithotripsy System recalled for generator recognition failure

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.

From the FDA notice · Read the official notice ↗ · All Olympus recalls

What to do

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

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 3 products — see all of them.

Details

Units affected
1082 units
Illnesses reported
None reported
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Classification
Class II
Recall number
Z-1478-2026

In the FDA's words

Description
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. 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. Model/Catalog Number: SPL-S; UDI: 00821925044197; Serial Numbers: All; Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan. Affected quantity: 1082 units
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.

3 products in this recall

Olympus ShockPulse-SE lithotripsy devices recalled for connection fault

Olympus is recalling three ShockPulse-SE lithotripsy system products, including the generator and reusable and single-use probes, with about 3,368 units affected. The generator can stay stuck in a blinking state and fail to recognize the transducer, which may be caused by damage to the transducer plug or generator receptacle. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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