—#218457

Product

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 (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.

FDA product code: FEO — Lithotriptor, Ultrasonic
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K171024
Affected lot / code info: Model/Catalog Number: SPL-SR, contains generator SPL-G; UDI: SPL-SR 00821925043824, SPL-G 00821925044203; Serial Numbers: CG5026, CG5027, CG5028, CG5029, CG5030, CG5031, CG5032, CG5033, CG5034, CG5035, CG5036, CG5037, CG5039, CG5040, CG5041, CG5042, CG5043, CG5045, CG5046, CG5047, CG5048, CG5049, CG5050, CG5051, CG5052, CG5053, CG5054, CG5055, CG5056, CG5057, CG5058, CG5059, CG5060, CG5061, CG5062, CG5063, CG5065, CG5066, CG5067, CG6037, CG6061, CG6069, CG6070, CG6071, CG6088, CG6094, CG6095, CG6096, CG6097, CG6098, CG6099, CG7000, CG7001, CG7002, CG7003;

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: International distribution in the country of Canada, Germany, Singapore, Australia, and India.

Timeline

Recall initiated: 2026-01-08
Posted by FDA: 2026-03-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218457. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.