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Stealthstation s8 application

Official notice

17 Oct 2023

Last checked

17 Oct 2023

Medium riskHealth Canada

An official Health Canada notice concerns Stealthstation s8 application. Medtronic identified a software anomaly that resulted in the surgical plan data shifting location(s) after the reference exam was changed. For this anomaly to occur, a pre-merge or diffusion-merge must have been used as the initial reference exam. Recall start date: September 26, 2023 Published 2023-10-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74432

Official notice

2023-10-17

The hazard

Medtronic identified a software anomaly that resulted in the surgical plan data shifting location(s) after the reference exam was changed. For this anomaly to occur, a pre-merge or diffusion-merge must have been used as the initial reference exam. Recall start date: September 26, 2023

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.

Recall Numbers

74432

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Affected products

Product 1

Affected products - Stealthstation S8 Application, Lot or serial number - N30873774 N30890766 0011209427 N30873773, Model or catalogue number - 9735762

Risk / hazard

Medtronic identified a software anomaly that resulted in the surgical plan data shifting location(s) after the reference exam was changed. For this anomaly to occur, a pre-merge or diffusion-merge must have been used as the initial reference exam. Recall start date: September 26, 2023

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: Medtronic Navigation, Stealthstation S8 Application.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74432

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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