| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00173-1 |
| Product Name/Description |
RayStation 3.5 and 4.0 (Radiation therapy treatment planning system)
ARTG Number: 195288 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has become aware of an issue found with the dose calculation in RayStation 3.5 and 4.0. The error appears in some situations for bolus/external/fixation/support structures that are outside the image stack but covered by the dose grid. When converted to dose grid structures, they are cut off at the image stack boundaries (first and last slice) in the inferior-superior direction. For a bolus/external/fixation/support structure this means that the part outside the image stack does not contribute to the density distribution and the dose calculation will be affected and may result in under dosing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Emergo is advising users to avoid the creation of treatment plans where the beam passes through a support or a fixation which is not imaged and where the support or fixation is placed on the superior or inferior side of the CT stack. Emergo is recommending the external ROI is not extended past the CT stack in the inferior or superior direction. If a bolus is used for the superior or inferior beams, users are advised to image enough slices above the patient head to fit the bolus inside the CT stack. Emergo is recommending users do not use dose tracking with oblique beams entering through the superior or inferior CBCT slice.
A software patch will be installed on all affected users to correct the issue. |
| Contact Information |
02 9006 1662 - Emergo Australia |