| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00521-1 |
| Product Name/Description |
Sensis system
Catalogue Numbers: 6634633, 6623974, 10764561 and 11007641
ARTG Number: 273953 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
In Sensis systems, a computer that is extremely dusty can cause problems when starting the system. In rare cases, it can cause the Sensis to fail. The system's functions cannot be used in the event of a failure and as a result, clinical treatment may need to be terminated, restarted, or transferred to a functioning system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is currently working on a solution and will update users in the second quarter of 2017. In the interim, users are requested to conduct a system check to ensure that the system is functioning properly prior to performing an examination. In the event that the system fails to start within the time and parameters described in the operator manual, users are requested to notify Siemens Service, and terminate, restart or transfer clinical treatment to a functioning system. Users are to ensure that standard emergency processes are in place for implementation in the event of a system failure.
This action has been closed out on 19/10/2018 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |