Z-1478-2026Class II

Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single...

Name: Z-1478-2026 Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single...
Creator: Olympus Corporation of the Americas
Published: 2025-11-14
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-11-14 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product... on 2025-11-14. FDA classified it as Class II and gives the reason as "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...". 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-1478-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-14
Posted: 2026-02-27
Recalling firm: OLYMPUS Corporation of the Americas
Product: Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S 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.
Product code: FEO Lithotriptor, Ultrasonic
Reason for recall: 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 tag: design
FDA 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 this product, identify and forward this notification to them.
Quantity in commerce: 1082 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
Product codes and lots: Model/Catalog Number: SPL-S; UDI: 00821925044197; Serial Numbers: All;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1478-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1477-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-02-27
Z-1478-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-02-27
Z-1479-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-02-27

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)