| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00303-1 |
| Product Name/Description |
Artis Q Systems with A100G generators
Catalogue Numbers: 10848353, 10848354, 10848355, 10848280, 10848281, 10848282, 10848283
ARTG Number: 273952 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
In Artis Systems with A100G generators, a component can be affected by ageing, resulting in the failure of a module in the high-voltage generator. When the failure occurs, the system usually responds by providing emergency fluoroscopy. In the worst case, a spontaneous failure of the radiation generation function is conceivable. In the event of a spontaneous failure, it may be necessary to cancel or restart a clinical treatment or transfer it to a functioning system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users that potentially affected modules will be replaced. Users are further advised to implement standard emergency processes in the event of a system failure and to have these processes carefully prepared until the affected modules are replaced.
This action has been closed-out on 23/03/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |