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 Aera, Magnetom Prisma, Magnetom Prisma Fit, Magnetom Skyra [Model or catalogue number: 10432914, 10849582, 10849583, 10432915; Multiple Lot or serial number] [HKMD No.: 120119, 140100].
According to Health Canada, the service pack NXA30A-SP02 is a bug fix update to improve stability and performance of NXVA30A-based MR systems. The service pack includes various internal improvements regarding the robustness of the basic Syngo and Numaris functionality.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/siemens-healthcare-magnetom
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 Jul 2022