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. Ingenia Elition X, Ingenia Elition S [Multiple product numbers] [HKMD No.: 190390].
According to TGA, the manufacturer advises that due to small mechanical imperfections, high resistance can occur in parts of the Gradient Chain in the MR system (for example, at the internal busbar terminals or connections), resulting in localised high currents. This high resistance may act as a heat source, which can lead to internal damage, causing downtime of the MR system.
The Gradient Chain in the MR system produces the desired magnetic field in three-dimensional space required for creating images.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2022-RN-00644-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Apr 2022