| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01035-1 |
| Product Name/Description |
Artis zee and Artis zeego systems (software versions VC14 and VC21) with the A100 generator and specific manufacturing lots of 3 focal spot x-ray tube (fluoroscopic angiographic x-ray system)
ARTG number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified a potential problem with the Artis zee and Artis zeego systems with the A100 generator and specific lots of a 3 focal spot x-ray tube. The “Small Focus” of a 3 focal spot x-ray tube may sporadically fail if the case grounding detaches from the focus head and overheating occurs. Further radiation release won’t be possible. An ongoing procedure can be continued by using one of the two remaining focal spots ("Large Focus” or "Micro Focus") instead. To achieve that, the operator will need to switch over to the other focus, thus causing a short interruption of the ongoing procedure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is implementing a software update that will protect the affected component from any damage in case the grounding detaches from the focus head. In case of such a potential failure, the system will automatically switch to the "Large Focus”. This action has been closed-out on 07/06/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |