| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01422-1 |
| Product Name/Description |
SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)
SOMATOM Definition AS (manufactured from May 2008 - Dec 2013)
Catalogue Number: 8098027
SOMATOM Definition Flash (manufactured from Sept 2009 - Jul 2012)
Catalogue Number: 10430603
ARTG Number: 274034 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has become aware that in rare cases the small light marker window used for the positioning laser and integrated in the front cover of the CT could loosen and potentially fall/drop out. This could lead to a risk of electrical shock or physical harm to fingers if a person touched the rotating or electrical parts of the gantry when reaching through the window opening. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is developing a solution for the problem and this will be implemented as a permanent correction. In the interim, users should maintain awareness until a solution is implemented. They should not use the CT system in case a light marker window is missing or loose and is advised to inform the Siemens Service immediately.
This action has been closed out on 07/11/2018 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |