| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00144-1 |
| Product Name/Description |
RayStation software versions 2.5, 3.0, 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 |
12/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
This notice concerns an issue found with the hybrid deformable registration in RayStation 2.5, 3.0, 3.5, and 4.0. Rigid registration is a standard first step prior to running a hybrid deformation. The rotation component of the rigid registration computed prior to the deformable registration is not accounted for in fusion views when mapping structures (regions or points of interest) or when deforming dose. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Emergo is advising their customers to ensure that the "discard rotation" option is selected in the Image Registration Module before creating a rigid registration intended to be used for hybrid deformable registration. End users can also use the ROI based deformable registration when applicable as this functionality is not affected by the error. A software patch will be release to correct this problem. |
| Contact Information |
02 9006 1662 - Emergo Australia |