| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01057-1 |
| Product Name/Description |
SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D Spiral"
ARTG Number: 164065 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
The use of the combination PHS1600 table with the perfusion scan mode 'Adaptive 4D Spiral' (typically used for critical diagnostic examinations) could occasionally initiate scan aborts. There is an increased risk of a scan abort when using the perfusion scan mode in combination with the PHS1600 table, especially when applying contrast media. Please note that the decreased performance stability is not affecting any other scan modes or the mechanical stability of the table in general. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is developing a solution for the use of the patient table PHS1600 in combination with the "Adaptive 40 Spiral" scan mode. Users are advised that they should be aware of the increased risk of a scan abort while using the perfusion scan mode in combination with the PHS1600 table. This action has been closed-out on 31/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |