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Shockpulse lithotripsy system, generator and transducer

Official notice

31 Dec 2025

MediumHealth Canada

An official Health Canada notice concerns Shockpulse lithotripsy system, generator and transducer. 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. Published 2025-12-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81442

Official notice

2025-12-31

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

SPL-S, SPL-G, SPL-T

Other

RA RA-81442

Model Numbers

SPL-S, SPL-G, SPL-T

Recall Numbers

81442

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Affected products

Product 1

Lot or serial number - All lots., Model or catalogue number - SPL-S

Product 2

Lot or serial number - All lots., Model or catalogue number - SPL-G

Product 3

Lot or serial number - All lots., Model or catalogue number - SPL-T

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Gyrus Acmi.

Source & status

Source

Health Canada

Tier

beta

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

81442

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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