| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00492-1 |
| Product Name/Description |
SOMATOM Emotion 6 / 16 Slice Configuration systems manufactured before February 2008
Catalogue/Lot number – 10165888, 10165977, 10415118, 10415119 systems manufactured before February 2008
ARTG number: 142119 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
The three bolts used to fix the balance weight of the data measurement system (DMS) may show signs of metal fatigue by producing an unusual noise whilst the gantry is in use and rotating. These bolts may potentially degrade over time and impact on stability of the balance weight. It should be noted that the rupture of a single bolt does not pose a hazard, however in the unlikely situation that all three bolts break, the DMS balance weight is likely to drop into the gantry.
This may cause serious patient injury and/or loss of scanned data and/or the machine rendered as out of service.
No case reports have been received indicating patient injury. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Service engineers will be replacing all the bolts holding the DMS balance weight with a new bolt design.
In the interim, to minimise a potential hazard Siemens recommends for users to carefully monitor the noise generated during gantry rotation. Since bolts will deteriorate over time, the balance weight will slowly change its position, potentially leading to a new sound pattern. Should users become aware of a change to the typical noise of the scanner we recommend that you immediately stop operation and contact a Siemens service engineer. This action has been closed-out on 05/09/2016. |
| Contact Information |
1800 310 300 Siemens Technical Support Centre |