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 biplane, ARTIS icono floor and Artis pheno with Large Display [Product codes: 11327600, 11327700, 10849000] [HKMD No.: 180011].
According to the TGA, in Electrophysiology (EP) catheter laboratories, there are many video sources to be displayed in one split screen layout on the Large Display. In case of shrinking the recording system video source, artefacts and/or loss of ECG/IECG details might occur. The quality of displayed ECG/IECG waveforms might be reduced when displayed in a smaller segment on the Large Display compared to the native video output resolution of the recording system, and analysis of the waveforms might be challenging for the operator in the examination room.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00969-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 Nov 2023