| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01185-1 |
| Product Name/Description |
RaySearch RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) (Radiation therapy treatment planning system)
ARTG Number: 195288 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Two issues have been identified with the dose calculation when using a region of interest (ROI) of type Fixation or Support with material override within the patient outline (External ROI) in RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0).
These are:
- When an ROI with material override overlaps a Fixation or Support ROI, the material used for dose calculation in the overlapping region may not be as intended.
- When a Support or Fixation ROI overlaps the patient outline (External ROI) in a dose grid voxel along the outer surface of the patient outline, the density used for dose calculation in that voxel may not be as intended.
These issues have not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A correction of these issues will be available in the next version of RayStation, scheduled for market release in December 2016. In the interim, users are advised that not to use ROIs of type Fixation or Support within the patient outline. Always use other ROI types for material override within the External ROI. A small overlap with the External ROI is acceptable if the Fixation or Support ROI is mainly outside the External ROI.
This action has been closed out on the 12/10/2018. |
| Contact Information |
02 9006 1662 - Emergo Australia |