| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00717-1 |
| Product Name/Description |
RaySearch RayStation 5
(Radiation therapy treatment planning system)
Affected software versions: 5.0.0.37, 5.0.1.11, 5.0.2.35
ARTG Number: 195288 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
This notice concerns an issue found with the treatment plan report in RayStation 5. For a treatment plan with multiple beam sets, the table for region of interest (ROI) plan dose statistics in the report may show the statistics for a beam set dose instead of the plan dose. In the case where a clinical decision is based on the erroneous ROI plan dose statistics, a patient could potentially receive a higher than acceptable radiation dose.
The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics. For such a report template, all reports for multiple beam set plans would always be affected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised to inspect all report templates that are intended to be used for plan with multiple beam sets, and to ensure that "POI Dose Statistics (Plan)" is included immediately before "ROI Dose statistics [Plan dose]" in the report content area. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 16/02/2017. |
| Contact Information |
02 9006 1662 - Emergo Australia |