Olympus recalls ShockPulse-SE Lithotripsy Generator model SPL-S due to power supply noise risks affecting treatment reliability. No remedy specified in official notice.
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
Olympus is recalling its ShockPulse-SE Lithotrypsy Generator model SPL-S because a miswired component can cause power supply noise. This noise may reduce system reliability and delay medical treatments.
The miswired component creates inconsistent power supply noise. This noise violates electromagnetic compatibility standards and could cause the system to malfunction during treatment, potentially delaying medical procedures.
Patients using this specific model for kidney stone treatment are affected. Medical professionals who operate the device are most at risk of treatment delays.
Check for model number SPL-S or serial numbers CG5085 and CG6009 on the device. This device was sold by Olympus Corporation of the Americas.
Identify the model number (SPL-S) and serial numbers (CG5085 or CG6009) to confirm if your device is affected.
The official recall notice does not specify any remedy.
Check for model number SPL-S or serial numbers CG5085 and CG6009 on the device.
The device may experience reliability issues that could delay medical procedures, but no immediate action is required.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1514-2022 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1514-2022 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.
