| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01186-1 |
| Product Name/Description |
Artis zee and Artis Q systems with software version VD11C
Catalogue/Lot Numbers: 10094137, 10848281, 10848282, 10848280, 10848283, 10094135, 10094139, 10848355, 10280959 and 10848353
ARTG Number: 273952 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified an issue whereby in the application “DSA Roadmap” the Artis system's intended behaviour is to reject the stored Vesselmap from previously acquired DSA if the patient table was moved during the Roadmap workflow. In rare cases the system does not reject the DSA Vesselmap and uses it for the further Roadmap workflow steps. Depending on the amount of table movement which was applied during the Roadmap workflow, the DSA Vesselmap may be overlaid as vessel tree at a position which does not fulfil Siemens' requirements for accuracy.
If the displacement of the vessel tree is large, it may be recognised by the user. However, if the displacement is either slight or at an unfavourable plane, the user may rely on incorrect visualisation of the catheter relative to the Vesselmap. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. The software in affected systems will be updated to correct the issue.
2. Users are to return the supplied acknowledgement form.
3. If the device is no longer in their possession forward the notice to the new owners.
4. Siemens will contact users to arrange a time to perform the software upgrade.
This action has been closed out on 15/10/2018 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |