| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01461-1 |
| Product Name/Description |
SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system)
ARTG Number : 274034 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Customers with software version VA50_SP2 will be provided an update to software version VA50_SP3. The installation of this update will address software bugs that were identified through field monitoring. Some of the major bug fixes that will be addressed with this software are:
1) Correction to volumetric misrepresentations of high contrast objects when using ADMIRE.
2) Correction to highly sporadic scan aborts due to temporarily tube currents at 0mA.
3) Correction to missing Microsoft Hotfixes (MS16-001, MS15-135, MS15-088, MS15-048).
4) Correction to highly sporadic image artefacts caused by error signals from high voltage chain at extremely high tube currents.
5) Correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed.
6) Correction to highly sporadic scan aborts due to temporarily high disk load of system disk.
7) Correction to highly sporadic image artefacts generated by scatter correction in case of tube arcing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised that the update will be remotely pushed to the system or Siemens will contact customers to arrange a date for the installation of the software update onsite. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |