Safety Alerts

Health Canada has posted a medical device safety alert concerning Siemens Healthcare Gmbh Magnetom Systems [Magnetom Aera, Magnetom Altea, Magnetom Avanto Fit, Magnetom Lumina, Magnetom Prisma, Magnetom Skyra, Magnetom Sola, Magnetom Sola Fit, Magnetom Vida; Multiple Model or catalog number] [HKMD No.: 120119, 200494, 200363, 140100, 190229, 180057].

According to Health Canada, 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.

For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/magnetom-systems

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 4 Jan 2023