Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Siemens Healthcare Gmbh Magnetom MRI System [Affected Products: Magnetom Aera, Magnetom Altea, Magnetom Avanto Fit, Magnetom Lumina, Magnetom Prisma, Magnetom Prisma Fit, Magnetom Skyra, Magnetom Sola, Magnetom Sola Fit, Magnetom Terra, Magnetom Vida, Magnetom Vida Fit, Tim 4G – Avantofit, Tim 4G - Skyra Fit; Model or catalog number: 10432914, 11344915, 11516216, 11344916, 10849582, 10849583, 10432915, 11291455, 11410482, 10882764, 11060815, 11410481, 10849578, 10849579, 10849580] [HKMD No.: 120119, 140100, 180057, 190229, 200363, 200494].
According to Health Canada, the manufacturer will be informing customers about potential dot or line-shaped artifacts caused by the presence of lubricating grease within the headband of the over-ear headphones when used during head examinations with the Magnetom MRI systems.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/magnetom-mri-system
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Sep 2023