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. Philips Ingenia Elition S and MR 7700 Systems with SW version R5.9 [Product codes: 46086 and 65009] [HKMD No.: 190390].
According to the TGA, multiple software issues for Philips Magnetic Resonance (MR) systems with SW version R5.9 that could affect the performance of the equipment. The issues have no clinical impact. The manufacturer will contact affected users to schedule time to visit sites and to install the software upgrade.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00894-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 Oct 2023