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 icono biplane [Model number: 11327600] [HKMD No.: 210368].
According to the TGA, the manufacturer is advising that during system tests an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation. In case the issue occurs, the system will switch to “Bypass fluoroscopy” mode. In “Bypass fluoroscopy” mode a limited imaging functionality (non-subtracted, continuous fluoroscopy with reduced power and without acquisition and storage of images) would remain available. This issue 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-2022-RN-00733-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 Jun 2022