Health product recall

MAGNETOM Prisma, Vida, Skyra, Verio Systems

Last updated

Summary

Product
MAGNETOM Prisma, Vida, Skyra, Verio Systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
MAGNETOM Prisma More than 10 numbers, contact manufacturer. 10849582
MAGNETOM Vida More than 10 numbers, contact manufacturer. 11060815
Tim 4G - Skyra Fit More than 10 numbers, contact manufacturer. 10849580
MAGNETOM Verio, System More than 10 numbers, contact manufacturer. 10276755
MAGNETOM Lumina More than 10 numbers, contact manufacturer. 11344916
Biograph mMR System More than 10 numbers, contact manufacturer. 10433372
MAGNETOM Skyra More than 10 numbers, contact manufacturer. 10432915
MAGNETOM Skyra Fit More than 10 numbers, contact manufacturer. 11516217
MAGNETOM Cima.X More than 10 numbers, contact manufacturer. 11647158
MAGNETOM Vida Fit More than 10 numbers, contact manufacturer. 11410481

Issue

This field safety corrective action addresses a potential safety issue associated with the magnet venting paths of some 3 Tesla MRI systems, which will require on-site inspection. An ice blockage may have built up within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up in the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Recall start date: August 14, 2025

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
Healthcare
Recall class
Type II
Recall date
Identification number
RA-77988

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe