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 Hologic, Inc. Selenia Dimensions/ 3Dimensions Mammography System [Model or catalog number: 3DM-SYS-INTL-3D; Software version 1.12.0/2.3.0] [HKMD No.: 210234].
According to Health Canada, after the release of the dimensions system software version 1.12.0/2.3.0 kits to the field, several users reported that c-view images were displaying a blurriness and lack of sharpness versus clear c-view images of the 1.11/2.2 release.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/seleniar-dimensionsr-3dimensionstm-mammography-system
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 09 Sep 2024