| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01436-1 |
| Product Name/Description |
RayStation and RayPlan
Model or Catalogue: RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5,
RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6)
Multiple Lot and Serial numbers
ARTG number:195288 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that an issue found with the electron dose calculation in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6). When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong.
To the best of our knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during beam modelling and treatment planning.
Electron dose calculation in RayStation uses a Monte Carlo dose engine, where a large number of particles are simulated. Each simulated particle is called a history, adding to the simulated dose. The number of histories can be adjusted for each dose calculation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Operators should inspect their product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice using the supplied Client Response Form.
Operators should not use a number of histories above 6 million for electron dose calculation and should inspect all commissioned electron beam models for any applicator calculated with greater than 6 million histories.
This issue will be resolved in the next version of RayStation, scheduled for market release in December 2017
This action has been closed out on 17/10/2018 |
| Contact Information |
02 9006 1662 - Customer Service Support |