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 systems with syngo Application Software version VE20 [ARTIS icono biplane model 11327600, ARTIS icono floor model 11327700, ARTIS pheno model 10849000, syngo Application Software model 11327667] [HKMD No.: 210368 and 180011, 170006].
According to MHRA, the manufacturer has identified the issue that after CT image data from Toshiba is loaded, unintended image mirroring can occur along the horizontal and vertical image axes.
For further information, please visit https://mhra-gov.filecamp.com/s/cmVpk0cO56sEilHN/d.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Feb 2022