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 GE Medical Systems Signa & Discovery MR [Including HKMD No.: 160090].
According to TGA, the manufacturer advises that there is a potential issue with its MR Systems. During the de-installation of an MR system magnet, if all rigging hardware (including rails and bolts) that attach to the magnet for transportation are not properly installed and secured, it may result in the magnet falling, leading to potential injury. It is critical to ensure that all hardware that is used to secure the magnet is not damaged and that the magnet is properly secured by the hardware when de-installing a magnet.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00482-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Mar 2022