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.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Philips Medical Systems Nederland Ingenia 1.5T, Ingenia Elition X and Ingenia Ambition X [Product number: 781396, 781358, 781356] [HKMD numbers: 120210, 190390, 200408].
According to the FDA, magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93737
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 5 Feb 2024
Updated on 7 Feb 2024