| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00136-1 |
| Product Name/Description |
AXIOM Artis Systems (fluoroscopic angiographic x-ray system)
Catalogue Numbers: 7412807, 7728392
Serial Numbers: 35031, 44018
ARTG Number: 102173 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
AXIOM Artis Systems with certain serial numbers are using flat detector cooling unit with inappropriate connectors that may leak. This might cause a system failure resulting in a drop out of the gantry system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
All connectors will be checked for leak tightness and an additional protection unit will be installed by Siemens' technicians. This will prevent leakages in the connector and therefore, the potential drop out of the gantry system can be avoided. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |