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 Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Philips Medical Systems Nederland B.V. MR Patient Support Ingenia Ambition S, Ingenia Ambition X, Ingenia Elition X [HKMD number: 200408, 190390].
According to the TGA, the manufacturer has identified a problem in the MR System Patient Support where the Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface. This could cause the screws to interfere with other moving parts, potentially blocking the horizontal table-top movement.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00798-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Sep 2024