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Syngo.via

Official notice

3 May 2022

Last checked

3 May 2022

Medium riskHealth Canada

An official Health Canada notice concerns Syngo.via. Shift of FMRI overlay and no direct possibility to correct the alignment contribute to an incorrect surgery planning when not detected: - The original error is not generated in the software but a manual error during the scan. - Incorrect anterior/posterior label can be detected by correlating/comparing with image anatomy. Recall start date: Apr 26, 2022 Published 2022-05-03.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64141

Official notice

2022-05-03

The hazard

Shift of FMRI overlay and no direct possibility to correct the alignment contribute to an incorrect surgery planning when not detected: - The original error is not generated in the software but a manual error during the scan. - Incorrect anterior/posterior label can be detected by correlating/comparing with image anatomy. Recall start date: Apr 26, 2022

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

64141

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Affected products

Product 1

Affected Products - Syngo.Via, Lot or Serial Number - More than 10 numbers, contact manufacturer., Model or catalog number - 10496180

Risk / hazard

Shift of FMRI overlay and no direct possibility to correct the alignment contribute to an incorrect surgery planning when not detected: - The original error is not generated in the software but a manual error during the scan. - Incorrect anterior/posterior label can be detected by correlating/comparing with image anatomy. Recall start date: Apr 26, 2022

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: Siemens, Syngo.via.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64141

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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