Olympus recalls specific ShockPulse-SE Lithotripsy System transducers with non-conforming materials that could allow water ingress during autoclaving. Affected units include serial numbers and lot numbers listed in the recall notice.
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
Olympus is recalling certain ShockPulse-SE Lithotripsy System transducers due to a manufacturing defect that could allow water to enter during sterilization. This poses a risk of equipment failure if the transducer is used improperly after sterilization.
The transducer contains non-conforming materials that could allow water to enter during autoclaving. This water ingress might cause the transducer to malfunction or fail after sterilization, potentially leading to equipment damage or treatment interruptions.
Healthcare professionals using the Olympus ShockPulse-SE Lithotripsy System transducers with the listed serial numbers and lot numbers are most at risk. Patients using these systems may also be affected if the transducer fails during treatment.
Check if your transducer has a serial number starting with 1910PW306077 or 1910PW306078, or a lot number from the list provided in the recall notice. The affected units were sold with specific serial numbers and lot numbers listed in the recall.
Verify if your transducer has a serial number listed in the provided range (1910PW30607705 to 1910PW30607809).
Confirm if your transducer's lot number matches any in the list (CG2000 to CG2037).
The transducer contains non-conforming materials that could allow water to enter during autoclaving, potentially causing malfunction after sterilization.
Check if your transducer has a serial number starting with 1910PW306077 or 1910PW306078, or a lot number from the list provided in the recall notice.
The recall does not specify a remedy, so contact Olympus directly for guidance on next steps.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2197-2020 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2197-2020 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.
