Recall Z-1494-2026 ยท FEO Lithotriptor, Ultrasonic
Olympus Corporation of the Americas
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (c
| Date | Mar 5, 2026 (initiated Jan 8, 2026) |
| Status | Open, Classified |
| Reason | Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices. |
| Root cause | Device Design |
| Action | On January 8, 2026, URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Examine your inventory and identify any affected devices. 2. Contact your Olympus Customer Service contact to obtain a Return Material Authorization and arrange for the return of your device. Olympus will repair the affected part at no charge and return the device back to you. 3. If you have further distributed the affected products, please forward this notification to other users who may have them. Olympus requests you to report any complaints related to the ShockPulse device to our |
| Quantity | 55 units (All OUS) |
| Distribution | International distribution in the country of Canada, Germany, Singapore, Australia, and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171024 | ShockPulse-SE Lithotripsy System Cybersonics, Inc., Aug 21, 2017 |