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 AXIOM Luminos TF, AXIOM Iconos R100 and R200, AXIOM Luminos Agile, Luminos Agile Max, AXIOM Luminos dRF, Luminos dRF Max and LUMINOS Lotus Max systems [HKMD No.: 120150, 130099].
According to the TGA, the manufacturer is informing of an update to the user manual which is being issued as a preventive measure to exclude any potential risk of patient injury caused by the foot rest detaching from the patient table during an examination.
If the foot rest is not connected and locked properly to the patient table, there is a risk that it could detach and the patient could slid off the table and be injured.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01460-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Dec 2022