FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: 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. Component: ShockPulse Lithotripsy System
- Recall number
- Z-0452-2026
- Recalling firm
- Olympus Corporation of the Americas
- 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. Component: ShockPulse Lithotripsy System
- Status
- Open, Classified
- Initiated
- 2025-10-08
- Posted
- 2025-11-07
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 1528 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.
- Lot, serial or model codes
- Model/Catalog Number: SPL-T; UDI-PI: 00855279005023; All serial numbers;
- 510(k) numbers
- ["K171024"]
- PMA numbers
- not on file
- Product code
- FEO
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28