| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00956-1 |
| Product Name/Description |
Ysio Systems with fixed detector in the wall stand, software version VC10 (Diagnostic digital x-ray system)
Catalogue Numbers: 10281013, 10281163
ARTG number: 102184 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has received several reports from customers that in case of Ysio with fixed detector in the wall stand, an unlikely error may occur, resulting in line artifacts in the image. Should these artifacts appear in the region of interest, the examination may need to be repeated. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens service engineer will contact affected customers to organise and implement a hardware upgrade which will resolve the issue. This action has been closed-out on 06/06/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |