Z-1514-2022Class II

ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S

Name: Z-1514-2022 ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Creator: Olympus Corporation of the Americas
Published: 2022-07-07
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-07-07 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S on 2022-07-07. 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.

Recall record

Recall number: Z-1514-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-07
Posted: 2022-08-11
Recalling firm: OLYMPUS Corporation of the Americas
Product: ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
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
FDA root cause: Process change control
Action: Olympus issued Urgent Medical Device Recall Letter dated July 7, 2022. Letter states reason for recall, health risk and action to take: 1. Immediately locate the generator with the serial numbers listed in this communication. The serial number is located on the back of the unit. 2. Your sales representative will work with you to arrange for the return of your unit and assist with initiating an order for a replacement unit. 3. Olympus requests that you acknowledge receipt of this letter by accessing the Olympus recall portal. Go to https://olympusamerica.com/recall. Enter the recall number 0410 and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please notify your customers of this removal action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Contact (647) 999-3203 or at [email protected] for any additional information or support concerning this matter.
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the states of AL, NM.
Product codes and lots: UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1514-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1514-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-11

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)