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 / pheno system in combination with a Siemens Healthineers VE OR Table [Model number: 4056869046877, 4056869063317 & 4056869149325] [HKMD No.: 180011, 210368].
According to the TGA, the manufacturer is informing users about a potential issue with the ARTIS icono / pheno system in combination with a Siemens Healthineers VE OR Table. During transversal table movement, it could happen that the rolling bearing which is part of the linear guide rail and enables the transversal table movement may get dislocated. The rolling bearing may fall out of the linear guide rail and thus the mechanical connection between table top and table base may get lost. As a result, the patient may fall off the table and the patient and/or the user may be injured.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01558-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Dec 2022