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Official recall record

ShockPulse Lithotripsy System, Generator and Transducer

Health Canada — Medical Devices · 2025-12-31 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2025-12-31
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

Olympus has identified instances of ShockPulse generator remaining in a blinking phase waiting to recognize the transducer following previous FY26-010 recall. Due to the potential for these issues to impact the functionality of the ShockPulse transducer, it is important a back-up transducer and probe are sterilized and available prior to procedure.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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