Recall Z-1477-2026 ยท FEO Lithotriptor, Ultrasonic
Olympus Corporation of the Americas
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR 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 i
| Date | Feb 27, 2026 (initiated Nov 14, 2025) |
| Status | Open, Classified |
| Reason | Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues. |
| Root cause | Device Design |
| Action | On or about December 18, 2025 URGENT: MEDICAL DEVICE CORRECTION - UPDATE letters were sent to customers. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the new Supplemental Guidance. Add a copy of this letter with the Supplemental Guidance to your existing Instruction for Use. You may continue to use the device according to this letter and 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 |
| Quantity | 602 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171024 | ShockPulse-SE Lithotripsy System Cybersonics, Inc., Aug 21, 2017 |