| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01086-1 |
| Product Name/Description |
Digital Linear Accelerators of type Primus, ONCOR and ARTISTE running Control Console software version 12.0.25 or 13.0.65 and syngo RT Therapist running software version 4.2.110 or 4.3.SP1
ARTG Number : 171515 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
17/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens are advising users regarding a bundled update of the syngo RT Therapist software and the Control Console software. The update addresses the following issues;
- Prevention from Automatic movements in case of significant risk of collision
- Re-positioning of 160 MLC after motion stop interlock
- Restart of Control Console
- Support of fractional monitor units for Virtual Wedge
- Lost information after plan UID change in Oncology Information System (OIS)
- Incorrect offset calculation in Advanced targeting Option
- Interrupt Cone Beam reconstruction
- Table rotation values for relative set up
- Wrong in-session resumption in case of 0 delivered monitor units
- Unexpected table movements after internal error message
- Dose linearity QA procedure for IMRT
- Configuration of auto sequence for bolus fields
- Workflow information for moving patient for treatment from one machine to another. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
These updates provide the corrections for previous recalls, with TGA Refs RC-2014-RN-00614-1, RC-2011-RN-00491-3 and RC-2012-RN-00592-3. The interim instructions are included in the previous recalls and include an update to the Instructions for Use (IFU) and work around instructions. A software upgrade will be implemented as a permanent correction. This action has been closed out on 16 June 2017. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |