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.
Medical device manufacturer, Philips Medical Systems Nederland B.V., has issued a medical device safety alert concerning its MR systems [Model: Achieva 1.5T, Achieva 1.5T Conversion, Achieva 1.5T Initial system, Achieva 3.0T, Achieva 3.0T for PET, Achieva 3.0T TX for PET, Achieva XR, Evolution upgrade 1.5T, Evolution upgrade 3.0T, Ingenia 1.5T, Ingenia 1.5T CX, Ingenia 1.5T S, Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Ambition S, Ingenia Ambition X, Ingenia Elition X, INGENUITY TF PET MR, Intera 1.5T, Marlin 1.5T, MR 5300, MR system 1.5T Marlin, MR-RT, MR-RT Upgrades, Panorama HFO, SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X, Sonalleve MR-HIFU 3.0T, Upgrade dStream] [HKMD No.: 110311,110501, 120210, 190186, 190390, 200408, 200409].
According to the manufacturer, an issue has been identified that the g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot (see figure 1) that may cause smoke/fire to alarm in the hospital’s technical room. The g-MDU, located in the technical room, is the single-entry point for the hospital electricity supply and distributes the electricity toward the various cabinets and components of the MR Scanner.
If the connection failure occurs, the user may observe the following:
If smoke or fire were to occur in the technical room, the risk to patients or operators may include asphyxia, eye irritation, eye redness, and/or delay in diagnosis.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 04 May 2024