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 Canon Medical Systems Corporation Interventional Angiography System [Product codes: INFX8000C; INFX-8000V] [HKMD No.: 230222].
According to the TGA, if the SPOT fluoro mode is activated, and the user changes the location of the ROI from the default position then changes the acquisition program, the collimator blades will return to the default position, whilst the display indicates no change.
In the case when the acquisition program is changed the displayed SPOT Fluoro x-ray exposure may be partially covered by the static image. This may lead to unintentional X-ray exposure to the region outside the selected ROI.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00921-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 Oct 2024