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 ceiling [HKMD No.: 230233].
According to the TGA, ARTIS icono ceiling systems are equipped with an automatic collision detection at locations where collisions with users or equipment might occur.
If the issue occurs, the collision sensor around the x-ray tube housing may show an unintended behaviour when switched off for a longer time (e.g. overnight) and then switched on. Therefore, the collision sensor may falsely signal non-existing collisions for up to half an hour.
While the collision sensor signals non-existing collisions, system movement is only possible with “override”-function, with very slow speed and without further collision protection. This may lead to a temporal unavailability of the system for diagnostic and therapeutic usage, especially in case of emergency.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00921-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Oct 2023