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Shockpulse-se lithotripsy system and shockpulse lithotripsy generator

Official notice

29 Jan 2026

MediumHealth Canada

An official Health Canada notice concerns Shockpulse-se lithotripsy system and shockpulse lithotripsy generator. Olympus discovered through an internal investigation that specific serial numbers of ShockPulse generators may have a mis-wired component. Users should contact customer service to arrange the return of their device for repair. Published 2026-01-29.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81508

Official notice

2026-01-29

The hazard

Olympus discovered through an internal investigation that specific serial numbers of ShockPulse generators may have a mis-wired component. Users should contact customer service to arrange the return of their device for repair.

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.

Lots

CG6086, CG7004

Skus

SPL-S, SPL-G

Other

RA RA-81508

Model Numbers

SPL-S, SPL-G

Recall Numbers

81508

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Affected products

Product 1

Lot or serial number - CG6086, Model or catalogue number - SPL-S

Product 2

Lot or serial number - CG6086, Model or catalogue number - SPL-G

Product 3

Lot or serial number - CG7004, Model or catalogue number - SPL-S

Product 4

Lot or serial number - CG7004, Model or catalogue number - SPL-G

Risk / hazard

Olympus discovered through an internal investigation that specific serial numbers of ShockPulse generators may have a mis-wired component. Users should contact customer service to arrange the return of their device for repair.

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

81508

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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