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 Siemens Healthcare GmbH ARTIS pheno, ARTIS icono biplane, ARTIS icono floor [Product code: 10849000, 11327600, 11327700; Model number: 4056869046877, 4056869063317, 4056869149325] [HKMD No.: 180011, 210368].
According to the TGA, due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur in case of performing excessive fluoroscopy/acquisitions. If this issue occurs a burning smell may be detectable, coming from the generator cabinet and the system may lose the imaging functionality of the corresponding place. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00577-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Jun 2023