Z-1494-2026Class II

Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy...

Name: Z-1494-2026 Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy...
Creator: Olympus Corporation of the Americas
Published: 2026-01-08
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-01-08 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number... on 2026-01-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1494-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-08
Posted: 2026-03-05
Recalling firm: OLYMPUS Corporation of the Americas
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.
Product code: FEO Lithotriptor, Ultrasonic
Reason for recall: 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 tag: design
FDA 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 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.
Quantity in commerce: 55 units (All OUS)
Distribution: International distribution in the country of Canada, Germany, Singapore, Australia, and India.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1494-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1494-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-03-05

Product code FEO

K171024Class IIShockPulse-SE Lithotripsy SystemCybersonics, Inc. / cleared 2017-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)