Olympus Recalls ShockPulse-SE Lithotripsy System Generators Over Recognition Failure
Olympus Corporation of the Americas has recalled 1,684 ShockPulse-SE Lithotripsy System generators due to hardware damage that prevents the device from recognizing the transducer.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of the ShockPulse-SE Lithotripsy System generator. According to the FDA, investigations identified instances where the 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 Products Are Affected
The recall affects the following medical device:
- Brand Name: ShockPulse-SE Lithotripsy System
- Product Name: ShockPulse-SE Lithotripsy System - Generator
- Model/Catalog Number: SPL-G
- UDI: 00821925044203
- Serial Numbers: All serial numbers are included in this recall.
- Quantity: 1,684 units
- Distribution: This is a worldwide distribution, including the United States, Canada, Mexico, Bolivia, Chile, India, China, the European Union, Singapore, Australia, Korea, and Japan.
What You Should Do
Olympus initiated the recall by sending notification letters to affected customers. Healthcare providers and facilities using the ShockPulse-SE system should inspect the transducer plugs and generator receptacles for signs of damage. For more information regarding the recall or to coordinate service, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034.
Why This Matters
The ShockPulse-SE system is used to fragment stones (calculi) during medical procedures. If the generator fails to recognize the transducer, the device cannot generate the necessary mechanical impacts or ultrasonic energy, potentially leading to procedural delays or equipment failure during surgery.
Source
Information provided by the FDA. Recall Number: Z-1479-2026.
Source: FDA Official Notice