Olympus ShockPulse-SE Lithotripsy System: Miswired Component May Cause System Failure
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.
Lower-risk 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. 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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/50186-olympus-shockpulse-se-lithotripsy-system-miswired-component-may-cause-system.
Source Summary by GovInfoNow · govinfonow.com/recall/50186-olympus-shockpulse-se-lithotripsy-system-miswired-component-may-cause-system · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1494-2026
Cite this page
“Olympus ShockPulse-SE Lithotripsy System: Miswired Component May Cause System Failure.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50186-olympus-shockpulse-se-lithotripsy-system-miswired-component-may-cause-system. Based on FDA recall #Z-1494-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1494-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Olympus- Category
Medical device
What to do — step by step
Check Device Serial Numbers
Review the serial numbers on your device to see if they match the list of affected units provided in the recall.
How this recall unfolded
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the device immediately?
No, the recall does not require immediate discontinuation. Affected units should be checked against the list of serial numbers.
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Where this comes from
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.
- Official source: FDA Recall #Z-1494-2026 (January 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1494-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.