| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00133-1 |
| Product Name/Description |
RaySearch RayStation 4.5, 4.7, 5, and 6
(Radiation therapy treatment planning system)
Build Numbers: 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24
ARTG Number: 195288 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Due to a known error in NVIDIA Graphics Processing Unit (GPU) card drivers, RaySearch has prevented GPU based computations for very large computation problems. In an incorrect Citrix XenApp configuration, the GPU may not be correctly identified and the erroneous calculation may be allowed. If this occurs, accelerated computation on GPU may give incorrect results for very large computation problems.
Dose computation will be affected if the dose grid contains more than 134217728 voxels for a photon plan or more than 67108864 voxels for a carbon ion plan. The main effect on calculated dose is that it may be incorrectly set to zero in parts of the dose grid. Normally this would be highly detectable. There may also be some smaller impact on the dose in the non-zero region. Deformable registration may be affected for large image sets. In a correct Citrix XenApp and GPU installation by RaySearch, the issue would not occur. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised to verify the GPU settings on each of the Citrix XenApp servers according to the instructions in the customer letter. A correct configuration of the RayStation GPU settings will show a graphics board that has been verified by RaySearch. Add the RSL-D-61-320-EN-1.0 RayStation 4.5, 4.7, 5 and 6 Additional System Environment Acceptance Test Protocol GPU to the location of the RayStation manuals. The tests in the Additional System Environment Acceptance Test Protocol GPU must be performed in addition to the tests in the System Environment Acceptance Test Protocol to verify GPU computations whenever the hardware or software platform is changed.
This action has been closed-out on 01/03/2018. |
| Contact Information |
02 9006 1662 - Emergo Australia |