| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00881-1 |
| Product Name/Description |
Symbia T Series and Symbia Intevo Camera System (SPECT/CT diagnostic imaging system)
Multiple catalogue numbers affected
ARTG Number: 123883 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens recently detected a rubber isolator with unfavourable aging properties. The function of this rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. In rare cases, when unfavourable aging has occurred, the rubber isolator may break and cause loss of support for the rotate motor. This event could lead to a rupture of the drive belt which in turn could damage the gantry covers and make contact with the patient. The possibility of a serious injury does exist if the belt makes contact with the patient. Siemens have not received any reports of injury with the Symbia T or Symbia lntevo camera systems as a result of this problem. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised that they can continue to use the systems while waiting for the corrective action to be undertaken which includes new mounting plate with improved rubber components and a backup device to ensure trouble free operation in the future. If users are experiencing abnormal noise or vibration, they are advised to immediately discontinue use and asked to contact their service engineer. Users are also asked to ensure that the safety advisory is placed in the System Owner's Manual. This action has been closed-out on 15/07/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |