| TGA Action ID |
RC-2025-RN-00514-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ARTIS pheno and ARTIS icono system on SW VE10B, VE21A and VE23B
Product code: 10849000, 11328100, 11327700, 11327600 |
| ARTG Number |
273952 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
In very rare situations, a failure may occur in the communication between the sensor responsible for measuring the dose area product and the corresponding software. As a result of this failure, the system may display an incorrect, significantly elevated dose value. However, the dose regulation is not affected by this failure and the applied dose is normal.
This situation represents a potential non-compliance with IEC 60601-2-43 that states the total uncertainty of the displayed values of the cumulative DOSIS AREA PRODUCT must not exceed 35 % for values above 2.50 Gy-cm2. |
| Instructions for Customers/Users |
Customers are to note that:
· If there are concerns regarding the recorded high dose, they should contact the service organisation for further assistance.
· The manufacturer is currently preparing a software update to correct this behaviour and ensure the correctness of the reported dose area product values. The correction is expected to be completed by Q1 2026.
· The service organisation will contact customers to schedule an appointment for the implementation of the corrective action.
This action has been closed out on 02/09/2026 |
| Action Commencement Date |
3/06/2025 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |