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

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of certain ShockPulse-SE Lithotripsy System components. Ongoing investigations identified instances where the device generator remains in a “blinking phase” while waiting to recognize the transducer. This failure to recognize the transducer is reportedly caused by damage to the transducer plug and/or the generator receptacle.

Which Products Are Affected

The recall involves the single-use probes used with the ShockPulse-SE Lithotripsy System. The following details identify the affected units:

• Brand Name: ShockPulse-SE Lithotripsy System SPL-S
• Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes
• Model/Catalog Number: SPL-S
• UDI: 00821925044197
• Serial Numbers: All serial numbers are included in this recall.
• Quantity: 1,082 units
• Distribution: Worldwide, including United States nationwide and international distribution to Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.

What You Should Do

Olympus initiated the recall through a formal notification letter to affected customers. Healthcare facilities and distributors possessing these units should follow the specific instructions provided in the firm’s notification. For additional information or inquiries regarding the return or inspection process, consumers can contact Olympus Corporation of the Americas at their headquarters: 3500 Corporate Pkwy, Center Valley, PA 18034-8229.

Why This Matters

The ShockPulse-SE system is an electromechanical device used to fragment calculi and aspirate stone debris during medical procedures. A failure in the generator’s ability to recognize the transducer can lead to device malfunction, potentially delaying or interrupting surgical treatments.

Source

This information is based on the official FDA Recall Notice (Recall Number: Z-1478-2026).