Olympus recalls ShockPulse-SE Lithotripsy System reusable probes due to potential transducer plug or generator receptacle damage from ongoing blinking issues. Affected units may require repair or replacement.
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.
Olymp: Olympus is recalling reusable probes for their ShockPulse-SE Lithotripsy System because ongoing investigations found the device's generator can stay in a blinking state, risking damage to the transducer plug or generator receptacle. This could lead to malfunction during medical procedures.
The generator may remain in a blinking phase, causing damage to the transducer plug or generator receptacle. This could lead to device malfunction during medical procedures that fragment kidney stones.
Patients undergoing lithotripsy procedures using the Olympus ShockPulse-SE system with the SPL-SR model probes are affected. Medical staff using these probes for stone fragmentation are at risk of potential device malfunction.
Check for the model number SPL-SR on the probe. The recall applies to all units sold by Olympus Corporation of the Americas.
Look for the model number SPL-SR on the probe to confirm if it is affected.
Ongoing investigations identified additional instances of the device generator remaining in a blinking phase, which may cause damage to the transducer plug or generator receptacle.
The recall record does not specify a remedy or action steps for affected units.
The recall record does not mention a risk of serious injury, only potential device malfunction.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1477-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1477-2026 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.
