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 Zee, Zeego, Q, Q.zen Systems [Multiple model numbers] [HKMD No.: 100488 and 140199].
According to TGA, the manufacturer is informing users that if the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damages and displays the message "NO XRAY: TUBE TOO HOT". In case the issue occurs, the system cannot be operated normally. 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-2022-RN-00371-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 03 Mar 2022