| TGA Action ID |
RC-2026-RN-00391-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ARTIS icono floor, ARTIS icono biplane, ARTIS icono ceiling delivered with software version VE40A and VE40B |
| ARTG Number |
273952 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In very rare situations, after increasing the detector lift height to its maximum or minimum, the system may lose its movement capability. A reboot may not re-establish movement control. This failure can be resolved only by qualified service personnel.
If this problem occurs, the system will report a failure of movement control and request a service call. It will not be possible to move the stand other than by emergency salvage procedures. Manual unmotorised table movements as well as fluoroscopy and acquisition will be still available. This may result in a situation where it is necessary to cancel the clinical procedure or to continue or begin the procedure on an alternative system. |
| Instructions for Customers/Users |
If the problem occurs an ongoing procedure might need to be terminated. Follow the instructions for emergency rescue in the Instructions for Use.
The software of the affected systems will be updated. The corrective action mitigates the probability of occurrence of the problem.
Siemens' service organisation will contact customers to arrange an appointment to perform the corrective action. Expected completion of correction is December 2026. |
| Action Commencement Date |
25/05/2026 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |