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 Shanghai Medical Equipment Ltd Luminos Fusion [HKMD No.:130472].
According to the TGA, there is a potential risk of the footrest detaching from the patient table on Luminos Fusion. If the footrest is not connected and locked properly to the patient table during an examination, there is a risk that it could detach, and the patient could slide off the table and be injured.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-01035-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 Dec 2023