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No image published for this recall

Magnetom systems

Official notice

3 Jan 2023

Last checked

3 Jan 2023

Medium riskHealth Canada

An official Health Canada notice concerns Magnetom systems. Sporadically, the distance measurement values displayed in MRI images on third-party postprocessing systems might be wrong if: - enhanced MRI images with rectangular FOV (field of view) are created at the MR scanner, and - in Syngo.via or MR view&go, the user rotates the images to display them in any orientation and saves them, and - afterwards, the user exports the images to another Dicom node using MR export rules (interoperability mode) the distance measurement values on newly created series might be displayed incorrectly on systems that receive these new images. Recall start date: December 21, 2022 Published 2023-01-03.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72510

Official notice

2023-01-03

The hazard

Sporadically, the distance measurement values displayed in MRI images on third-party postprocessing systems might be wrong if: - enhanced MRI images with rectangular FOV (field of view) are created at the MR scanner, and - in Syngo.via or MR view&go, the user rotates the images to display them in any orientation and saves them, and - afterwards, the user exports the images to another Dicom node using MR export rules (interoperability mode) the distance measurement values on newly created series might be displayed incorrectly on systems that receive these new images. Recall start date: December 21, 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

72510

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Affected products

Product 1

Affected products - Magnetom Lumina, Lot or serial number - 196408 196406 196427, Model or catalog number - 11344916

Product 2

Affected products - Magnetom Skyra, Lot or serial number - 45186 45281 45446 45166 45087 145249 45768 145034 45934 45961 45370 145335 45447, Model or catalog number - 10432915

Product 3

Affected products - Magnetom Sola Fit, Lot or serial number - 202567 202589 202562 202570, Model or catalog number - 11410482

Product 4

Affected products - Magnetom Vida, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 11060815

Product 5

Affected products - Magnetom Altea, Lot or serial number - 189602 189915 189956 189700 190027, Model or catalog number - 11344915

Product 6

Affected products - Magnetom Sola, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 11291455

Product 7

Affected products - Magnetom Aera, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 10432914

Product 8

Affected products - Magnetom Prisma, Lot or serial number - 166026 166139 166247 66071 166208 66108, Model or catalog number - 10849582

Product 9

Affected products - Magnetom Avanto Fit, Lot or serial number - 211019, Model or catalog number - 11516216

Risk / hazard

Sporadically, the distance measurement values displayed in MRI images on third-party postprocessing systems might be wrong if: - enhanced MRI images with rectangular FOV (field of view) are created at the MR scanner, and - in Syngo.via or MR view&go, the user rotates the images to display them in any orientation and saves them, and - afterwards, the user exports the images to another Dicom node using MR export rules (interoperability mode) the distance measurement values on newly created series might be displayed incorrectly on systems that receive these new images. Recall start date: December 21, 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, Magnetom.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

72510

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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