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TGA Action ID RC-2025-RN-00436-1
Type of Product Medical Device
Product Name/Description Artis ICONO (Software VE40 in combination with the F-CPU on Angio-CT)

Material number: 11328100
ARTG Number 273952
Action Type Product Correction
Action Level Hospital
Hazard Classification Class II
Reason for the Action With the update of software to VE40, there is a change in the behaviour of the system movement in a collision zone when the Emergency STOP button on the CT is activated.

After the update of the system software from VE23 to VE40 the Proximity and the Enable X-Ray Signal of the Customized Solutions Interface (CSI) is not forwarded from the CCOM (SCU, Angiomatic). The active (low active) Signals of the CSI will be ignored.

The problem only occurs with the System Software VE40 in combination with the F-CPU. It does not occur with the System Software VE23 (delivered with F-CPU) or VE40 (delivered with SinumerikOne).

When the Emergency STOP button on the CT is activated, the system stops for approx. 1 sec. If the joystick is still deflected the system starts to move again at slow speed (before VE40, the system stops), also in direction of the possible collision. In addition, without the Enable X-Ray signal, the Artis system allows the release of X-Rays while a CT scan is being loaded (in the past the radiation was blocked). If an X-Ray is released on Artis, the loading of CT scan is interrupted.
Instructions for Customers/Users Users are to follow instructions provided in the updated Addendum to Operator Manual:
- Angio-CT one room inline setup - 11690818 CGA 01S 00 CS 13782
- Angio-CT two room inline setup - 11691286 CGA 01S 00 CS 14250

The manufacturer is currently investigating if any additional actions may be required to further mitigate possible risks.

This action has been finalised on 06/01/2026.
Action Commencement Date 6/05/2025
Responsible Entity Siemens Healthcare Pty Ltd
Contact Information 1800 310 300 - Customer Care Centre