Olympus Recalls ShockPulse-SE Lithotripsy System Reusable Probes Due to Recognition Issues

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of the ShockPulse-SE Lithotripsy System Reusable Probes. Ongoing investigations identified instances where the device generator remains in a “blinking phase” while waiting to recognize the transducer. This malfunction is caused by damage to the transducer plug and/or the generator receptacle, which prevents the system from functioning as intended.

Which Products Are Affected

The recall affects the following medical device components:

• Brand Name: ShockPulse-SE Lithotripsy System SPL-SR
• Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes
• Model/Catalog Number: SPL-SR
• UDI: 00821925043824
• Serial Numbers: All serial numbers are included
• Quantity: 602 units

This recall impacts products distributed worldwide, including the United States, Canada, Mexico, Bolivia, Chile, India, China, the European Union, Singapore, Australia, Korea, and Japan.

What You Should Do

The recall was initiated via a notification letter to affected customers. Healthcare facilities and providers using the ShockPulse-SE Lithotripsy System should inspect their equipment for damage to the transducer plug or generator receptacle. If the generator remains in a blinking phase and fails to recognize the transducer, the device should not be used. For further information regarding returns or technical support, contact Olympus Corporation of the Americas at their Center Valley, PA headquarters.

Why This Matters

The ShockPulse Lithotripsy System is a critical electromechanical device used to fragment calculi and aspirate stone debris during medical procedures. A failure of the generator to recognize the transducer can lead to procedural delays or the inability to perform the lithotripsy as required.

Source

Information provided by the FDA under Recall Number Z-1477-2026.