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 Administration (TGA) has posted a medical device safety alert concerning Philips Medical Systems Nederland B.V. Zenition 70 systems (Model Number: 718133) [HKMD No.: 190388].
According to the TGA, there is a possibility of unintended radiation exposure while using the wired footswitch or handswitch. The requirement from the standard states that X-ray stop time should not exceed 100 milliseconds once the footswitch or handswitch is released to stop the X-ray. However, there might be a possibility when a Zenition 70 system is used in 2fps subtract mode for a vascular surgery procedure, the time to stop X-ray might exceed by 18 milliseconds over and above the 100 milliseconds.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00361-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 May 2024