| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00457-1 |
| Product Name/Description |
SOMATOM Emotion 6 / 16 Slice Configuration and SOMATOM Spirit/Spirit Power Systems (Full-body computed tomography (CT) diagnostic x-ray system)
Catalogue numbers: 10045692, 10165566, 10165888, 10165977, 10415118, 10415119, 10415116 & 10415117
ARTG number: 142119 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
17/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
The mechanical function of the rubber damper, which is situated within the mounting assembly of the rotation motor, may potentially degrade over time and may impact stability. In rare cases, the rubber damper may break and cause the loosening of the mounting plates in the gantry. This event is not posing a hazard by itself but could lead to a rupture of the drive belt and subsequently to a scan abort. Additionally the broken belt may damage the system cover so that the contact protection against rotating parts inside the gantry can’t be granted for the operator and patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising that there is no workaround for the user to minimise the potential risk of this issue. Siemens has developed a modification for the affected systems which is to replace the rotation motor mounting plate inside the gantry of the CT system by a new model. This new mounting plate includes significantly improved rubber dampers for the stability of the assembly. This action has been closed-out on 12/02/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |