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 Administration (TGA) has posted a medical device safety alert concerning Siemens Healthcare GmbH ARTIS icono systems with small detector and the according collimator [Product Codes: 11327700 and 11328100] [HKMD No.: 210368, 230233].
According to the TGA, in very rare situations, the first x-ray release after patient registration might be performed with a wrong copper prefiltration. After an acquisition or significant changes in the projection or angulation the problem will automatically be resolved.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00457-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 Jun 2024