Safety Alerts

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Siemens Healthcare GmbH ARTIS icono biplane, ARTIS icono floor, ARTIS pheno [Model Number: 11327600, 11327700, 10849000; SW version VE20 to VE21] [HKMD No.: 210368 and 180011].

According to MHRA, the manufacturer is informing users of potential issues with ARTIS systems with software versions VE20 to VE21:

• Issue 1: Indication of block movements function
• Issue 2: Blocked table/ stand movement in case of broken drive connection
• Issue 3: 3D run with manually rotated flat detector
• Issue 4: Stopped and blocked system movements on the ARTIS pheno system
• Issue 5: Missing movement stop with multiple collision sensor activation

For further information, please visit https://mhra-gov.filecamp.com/s/t4ciC5TDnVLtrnxv/d

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 23 Feb 2022