Health product recall

Magnetom Systems

Last updated

Summary

Product
Magnetom Systems
Issue
Medical devices - Performance
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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