Olympus Corporation Of The Americas ShockPulse-SE Lithotripsy System SPL-S: ShockPulse-SE Lithotripsy System

Source: FDA | Recall date: 03/11/2026

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Affected product: ShockPulse-SE Lithotripsy System SPL-S: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of

Brand: olympus corporation of the americas

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.

Official identifiers

FDA recall number: Z-1478-2026
FDA event number: 98359

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