| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01298-1 |
| Product Name/Description |
SOMATOM CTs: Definition Flash, Definition Edge, Definition AS and Definition (full body CT diagnostic x-ray systems) equipped with software syngo CT2010A, CT2010B, CT2011A and CT2012B
ARTG Number: 164065 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is a sporadic malfunction concerning 3D reconstructions during activated "Preview Image" functionality. The problem may occur during the process of 3D recon job planning and editing within the "Examination" card while the "Preview Image" functionality is activated; when switching then to another recon job the system might sporadically hang up. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The customer letter identifies the software workarounds to mitigate the problems temporarily. Siemens will schedule software upgrades shortly for mitigating the problems permanently. |
| Contact Information |
1800 310 300 - Siemens Regulatory Affairs |