| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00558-1 |
| Product Name/Description |
Ysio Systems (X-ray system)
Catalogue Numbers: 10281013 & 10281163
ARTG Number: 102184 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
If excessive liquid is used for cleaning, the liquid may infiltrate the generator console and cause a short circuit which may lead to an unintended release of radiation. To date, only one customer has reported this occurrence. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens has prepared a modification to resolve the potential issue by sealing the generator consoles of the Ysio Systems against infiltration of liquid. This modification will be installed as field correction likely to occur during 2nd to 4th quarter 2014. Until the modification is implemented, users are advised to strictly follow the user manual to avoid liquid infiltration into the generator console. This action has been closed-out on 18/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |