| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01364-1 |
| Product Name/Description |
RaySearch RayStation 5 (Radiation therapy treatment planning system)
Software build number: 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 |
17/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference (FoR) as the displayed auxiliary CT set exists in another case, the dose display may be incorrect. The issue occurs when a plan in one case is used to compute dose on another image set, and when that image set has the same FoR as an image set in another case. This happens when using the function “Compute Dose on Other Data Set” in the Plan Evaluation module or when computing fraction doses in the Dose Tracking module. The visual display of dose in the patient views can be incorrect and can be shifted and/or rotated. The display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. The dose value normally displayed in the upper left corner when pointing in the 2D view may be incorrect or missing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The issue will be resolved in the next version of RayStation, scheduled for market release December 2016. Until a corrected version has been installed, all affected users must maintain awareness of the issues. Specifically, be aware that when a patient has multiple cases, the following may be incorrect if there are image sets that share the same Frame of Reference residing in different cases:
- Display of evaluation dose computed on another CT image set
- Dose tracking fraction dose and deformed dose.
In these cases, the display of the dose values in the 2D view, including the dose value shown when pointing in the view, maximum dose position, dynamic isodose lines and dose grid display may be incorrect.
This action has been closed out on the 12/10/2018. |
| Contact Information |
02 9006 1662 - Emergo Australia |