| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00648-1 |
| Product Name/Description |
Axiom Artis and Artis Zee Systems with hand switch (Fluoroscopic angiographic X-ray system)
Hand Switch Material Number: 3771750
ARTG Numbers: 102173 and 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
A problem may occur if the connection between cable connection and hand switch is contaminated with a large amount of fluid. In a worst case situation, uncontrolled release of a x-ray image may happen. The system terminates uncontrolled X-ray after a short period. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens service personnel will contact affected customers to organise for the removal of the cable extension. The hand switch will be directly connected to the patient table preventing the issue from occurring. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |