| TGA Action ID |
RC-2025-RN-00903-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Sectra PACS (Sectra Core)
All versions prior 27.2 |
| ARTG Number |
152846 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A critical security vulnerability has been identified in Sectra Core during software development.
Successful exploitation may lead to remote code execution (RCE) on the server running the service. This can lead to loss of confidentiality, integrity and availability of patient health information in the Sectra Core system. Clinical implications include, but are not limited to, delayed or incorrect treatment or diagnosis.
There has been no reported exploitation of the vulnerability.
This market action was undertaken prior to TGA notification. |
| Instructions for Customers/Users |
The vulnerability is remediated in software patches. Customers were contacted apply the patches.
This action has been closed out on 03/12/2025. |
| Action Commencement Date |
21/10/2025 |
| Responsible Entity |
|
| Contact Information |
0424 128 128 - Lee Speir, Sectra |