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 United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Siemens Healthcare GmbH Artis system [Artis Q floor, Artis Q ceiling, Artis Q biplane, Artis Q zeego, Artis Q.zen floor, Artis Q.zen ceiling, Artis Q.zen biplane, Artis Q zeego, Artis zee floor, Artis zee ceiling, Artis zee multi-purpose, Artis zee biplane, Artis zee floor MN, Artis zee biplane MN, Artis zeego, Artis zee III floor, Artis zee III ceiling, Artis zee III multi-purpose, Artis zee III biplane, Artis zeego III, Artis zee III floor MN, Artis zee III biplane MN] [HKMD number: 100488, 140199].
According to the MHRA, the manufacturer has identified that if the coolant level in the tube 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 Artis system will display the message “TUBE HOT, have a break”. Several minutes later the Artis system will block X-ray to prevent further damages and displays the message “NO XRAY: TUBE TOO HOT”.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/ncrYcR83aokYJ0og
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 5 Apr 2024
Updated on 7 May 2024