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Safety Alerts and Communications

Safety Alerts

Safety Alerts

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.

Medical Device Safety Alert: Imaxeon Pty Ltd MEDRAD Centargo CT Injection System

18 Nov 2024

The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Imaxeon Pty Ltd MEDRAD Centargo CT Injection System [HKMD No.: 220403].

According to the TGA, in August 2024, Microsoft disclosed a cybersecurity vulnerability impacting systems with IPv6 enabled. This vulnerability would allow an unauthenticated attacker, in a worst-case scenario exploit, to obtain full system access. Only the Centargo Injector System is vulnerable.

For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-01021-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 18 Nov 2024

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