| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00377-1 |
| Product Name/Description |
SOMATOM go.Up and SOMATOM go.Now
Catalogue numbers: 11061628 and 11061618
ARTG number: 142119
(Siemens Healthcare - X-ray system, diagnostic, computed tomography, full-body) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified that the following issues with SOMATOM go.Up and SOMATOM go.Now may require an additional scan that exposes the patient to an additional X-ray dose:
1: Software stability problems preventing the start of a reconstruction after the CT examination. If these problems occur, this is indicated by a red cross in the “Job Status” table.
2: Impact on image quality: If the detector is still in adjustment mode at the time the scan command is provided from the control box, severe streak artefacts may occur.
3: Only for customers using syngo Osteo CT: If the scan/recon tab card is closed after an osteoporosis scan of a patient but before the intended Osteo reconstruction has been completed, the Osteo reconstruction cannot be continued or completed at a later point in time. In this case, a rescan would be necessary to complete the Osteo reconstruction. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Siemens is advising that the stability and quality issues are solved by the software updates VA10A_SP2 and VA20A. The Osteo reconstruction issue is solved with the VA20A software update. Siemens will be informing users as soon as the update(s) are available for their systems.
In the interim, users should refer to the information provided in the Customer Letter for an Operator workaround for the issues identified.
This action has been closed out on the 06/12/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care |