| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00734-1 |
| Product Name/Description |
RaySearch RayStation 3.0 and 3.5 (software versions 3.0.0.251, 3.5.0.16, 3.5.1.6) (Radiation treatment planning and analysis software)
Date Manufactured: 15/02/2013
ARTG Number: 195288 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Under certain conditions resampling of regions of interest (ROI) geometries to the dose grid representation is not correctly calculated, and an additional voxel layer is added incorrectly on the superior side of each ROI. The problem is more pronounced for very small ROI's, leading to over-estimation of dose maximum and under-estimation of the minimum dose.
The above problem also affects dose calculated with material overrides, however this should cause no noticeable impact. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Emergo are providing work around instructions for users to follow. The issue will be corrected in RayStation software version 4.0 which is due for release in July 2013. |
| Contact Information |
02 9006 1662 - Emergo Group |