| TGA Action ID |
RC-2026-RN-00759-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ARTIS pheno, ARTIS icono floor, ARTIS icono biplane, ARTIS icono ceiling with software version VE50B (only systems that were upgraded to VE50B)
ARTIS pheno
Product Code: 10849000
ARTIS icono floor
Product Code: 11327700
ARTIS icono biplane
Product Code: 11327600
ARTIS icono ceiling
Product Code: 11328100 |
| ARTG Number |
273952 |
| Unique Device Identifier (UDI) |
04056869063317, 04056869295923, 04056869149325, 04056869046877 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In certain operating situations, the system may fail to execute movement control commands as intended. If this occurs, motorised stand and/or table movement may no longer be available until the system has been completely restarted. The impact on system operation is that movement of the affected system axes may no longer be possible until the system is restarted.
This may limit or delay the ability to change projection planes or to position the system as required for the intended procedure. In situations where immediate access to the patient or repositioning of the system is required, including during cardiopulmonary resuscitation (CPR) activities, the described behaviour may interfere with the intended workflow. |
| Instructions for Customers/Users |
Customers should read the customer letter and perform all instructions provided in this letter.
Ensure that all users of the affected system are informed of this problem and are familiar with the applicable patient rescue and emergency procedures described in the Operator Manual.
No specific retrospective patient follow-up is currently considered necessary with regard to this problem.
The manufacturer is currently investigating the underlying cause of the reported system behaviour with high priority. Until the root-cause investigation has been completed no additional specific risk mitigation measures beyond the information provided in this letter have been defined at this time.
If additional actions are identified as necessary based on the outcome of the investigation, affected customers will be informed accordingly. |
| Action Commencement Date |
30/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |