ShockPulse Lithotripsy Transducer (Olympus) – startup failure (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T 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. Com
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Model/Catalog Number: SPL-T, UDI-PI: 00855279005023, All serial numbers
Products Sold
Model/Catalog Number: SPL-T; UDI-PI: 00855279005023; All serial numbers;
Olympus Corporation of the Americas is recalling Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog N due to The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
Recommended Action
Per FDA guidance
On October 8, 2025 URGENT: MEDICAL DEVICE ADVISORY NOTICE letters were sent to customers. Actions to be taken: Ensure you read the content of the notice. Ensure that all personnel are aware and knowledgeable on the content of the notice. You may continue to use the device according to the instruction for use, which cautions users to ensure that a back-up transducer and probe are sterilized and available prior to beginning a procedure. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you acknowledge receipt of this letter with the provided reply form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026