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 Luminos dRF Max, MOBILETT Elara Max, YSIO Max and YSIO X.Pree [Model: VF10K_SP05, VF10K, VF10K_SP05, VF10K, VF11H, VE10ZA, VF10F_HF05, VA10F_HF03] [HKMD number: 120150, 190357, 110451, 210199].
According to Health Canada, Siemens Healthineers was informed by the detector manufacturer that magnetic connectors may have been supplied as spare parts for portable detectors. If magnetic connection units are installed, a permanent (static) magnetic field is generated that exists independently of the operation of the detector. This can affect the function of implantable electronic devices such as pacemakers or implantable defibrillators if a minimum distance of >5 cm from the implanted device is not maintained.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/luminos-drf-max-mobilett-elara-max-ysio-max-and-ysio-xpree
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 Jul 2024