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Olympus ShockPulse-SE Lithotripsy System Generator
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MEDICAL DEVICE RECALLMODERATE

Olympus ShockPulse-SE Lithotripsy System Generator

Olympus is recalling the ShockPulse-SE Lithotripsy System generator due to a wiring issue that may cause treatment delays.

What to do

Contact your Olympus representative to schedule a service inspection and repair of the affected generator units.

Recalled
Listed
Updated
Recall No.
Z-1494-2026
Agency
FDA
Firm
Olympus Corporation of the Americas
Recall ID
98360
Status
ONGOING

Recall at a glance

Quantity recalled
55 units (All OUS)

Why it was recalled

Olympus is recalling the ShockPulse-SE Lithotripsy System generator due to a mis-wired component that can cause electromagnetic interference. This noise may decrease system reliability and potentially lead to a delay in medical treatment.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Olympus ShockPulse-SE Lithotripsy System with Generator ShockPulse-SE Lithotripsy System - Reuseable ProbesModel/Catalog number: SPL-SR, contains generator SPL-G

UDI-DI
00821925043824, 00821925044203
–

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification