| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00077-1 |
| Product Name/Description |
Artis Zee Systems equipped with a card collimator
Artis Zee material numbers: 10094135, 10094137 and 10094141
Card collimator material numbers: 10092591, 10092593, 10092601, 10092631 and 10092632
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
At the card collimators of these systems, a dislocation of the scatter radiation filter inside the card collimater may occur.
This recall action was carried out prior to approval of the recall strategy by the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing a replacement filter to fix the issue. |
| Contact Information |
1800 310 300 - Siemens Regulatory Affairs |