| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01358-1 |
| Product Name/Description |
MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators
Multiple product codes
All serial numbers
ARTG number: 165502 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has received reports of one circuit board (G41) located inside of the linac gantry showing signs of overheating. After a detailed analysis the root cause was found to be one of the components that belong to this board (Head Driver PCB). Siemens has redesigned the Head Driver PCB to further mitigate the risk of local overheating on the G41 motherboard. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens has redesigned the Head Driver PCB to further mitigate the risk of local overheating on the G41 motherboard. The present corrective action comprises the replacement of the Head Driver PCB by a redesigned component on your LINAC. This action has been closed-out on 12/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |