Health product recall

Magnetom Systems

Last updated

Summary

Product
Magnetom Systems
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products Lot or serial number Model or catalog number
Magnetom Lumina 196408 196406 196427 11344916
Magnetom Skyra 45186 45281 45446 45166 45087 145249 45768 145034 45934 45961 45370 145335 45447 10432915
Magnetom Sola Fit 202567 202589 202562 202570 11410482
Magnetom Vida More than 10 numbers, contact manufacturer. 11060815
Magnetom Altea 189602 189915 189956 189700 190027 11344915
Magnetom Sola More than 10 numbers, contact manufacturer. 11291455
Magnetom Aera More than 10 numbers, contact manufacturer. 10432914
Magnetom Prisma 166026 166139 166247 66071 166208 66108 10849582
Magnetom Avanto Fit 211019 11516216

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Siemens Healthcare Gmbh

Henkestr. 127, Erlangen, Germany, 91052

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-72510

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