| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00284-1 |
| Product Name/Description |
Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13.0.302
ARTG Number: 165502 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified a risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table using the SIMTEC Auto Field Sequence Option.
The following issues will be addressed in the software update solution "Auto Field Sequence (AFS) Motion Protection”:
- Risk of collision due to automatic gantry movements in case of lateral table shifts and
- Unwanted automatic gantry movements in case of table configuration set to “Manually” and the movement order to be “Table first”. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising affected users to be aware of the updated software solution “Auto Field Sequence (AFS) Motion Protection” which will be implemented at the Control Console of their Digital Linear Accelerator. This software will not execute a movement if a potential collision is anticipated and that users may, in such cases, perform the planned movement manually. Users are further advised that despite these safety measures, there might be scenarios which are not covered by the software. Therefore, during an auto-sequence delivery, users must be aware, at all times, of any movement of the gantry, the treatment table and the applied table offsets or overrides according to the treatment plan.
This action has been closed-out on 23/03/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |