Olympus recalls ShockPulse-SE Lithotripsy Systems with miswired components that could cause noise and reliability issues, potentially delaying kidney stone treatment. Affected units include specific serial numbers and models.
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. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
Olympus is recalling certain ShockPulse-SE Lithotripsy Systems due to a miswired component that may cause noise and reliability problems, potentially delaying kidney stone treatment. This affects specific models and serial numbers.
The miswired component can cause noise on the power supply output, which may not meet electromagnetic compatibility standards. This could reduce system reliability and lead to delays in treating kidney stones.
Healthcare providers using the Olympus ShockPulse-SE Lithotripsy System for kidney stone treatment are most at risk. Patients receiving treatment with affected units may experience delays.
Check for the model SPL-SR with generator SPL-G. Affected units have specific serial numbers listed in the recall notice, including CG5026 to CG7003.
Review the serial numbers on your device to see if they match the list of affected units provided in the recall.
The miswired component can cause noise on the power supply output, which may not meet electromagnetic compatibility standards and could reduce system reliability.
Check the serial numbers on your device against the list of affected units provided in the recall notice, which includes CG5026 to CG7003.
No, the recall does not require immediate discontinuation. Affected units should be checked against the list of serial numbers.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1494-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1494-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
