Olympus recalls ShockPulse-SE Lithotripsy System single-use probes due to potential generator blinking causing transducer damage. Affected units have model SPL-S and all serial numbers. No remedy specified in recall notice.
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.
Olympus is recalling its ShockPulse-SE Lithotripsy System single-use probes because ongoing investigations found the device's generator may stay in a blinking state, risking damage to the transducer plug or receptacle. This could lead to device malfunction during medical procedures.
The generator may remain in a blinking phase waiting to recognize the transducer, which can damage the transducer plug or generator receptacle. This could cause device malfunction during stone fragmentation procedures.
Patients receiving lithotripsy treatments using the ShockPulse-SE system are most at risk. Healthcare providers using the system with the affected probes may also be impacted.
The product has model number SPL-S and all serial numbers. The ShockPulse-SE Lithotripsy System single-use probes are used in medical procedures to break kidney stones.
Identify if your probes have model number SPL-S and any serial numbers.
Ongoing investigations found the device generator may stay in a blinking phase, risking damage to the transducer plug or receptacle.
The recall notice does not specify a remedy, so no action is required beyond checking if your probes have model SPL-S.
The recall states potential device malfunction but does not specify injury risks.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1478-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1478-2026 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
