| TGA Action ID |
RC-2026-RN-00228-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ARTIS pheno shipped with VE10 updated to VE30 or VE40 Software
Product Code: 10849000 |
| ARTG Number |
273952 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
An error has been identified in the 3D program parameters for ARTIS pheno systems that have been updated from VE10 to VE30 or VE40.
During 3D runs, lighter and darker patient images may be acquired which may result in less accurate 3D reconstruction.
The operation of the system is not impacted for 2D applications. |
| Instructions for Customers/Users |
This problem will be corrected in a software update.
Siemens' service organisation will contact customers to schedule the update. |
| Action Commencement Date |
31/03/2026 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |