| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01103-1 |
| Product Name/Description |
RayStation 3.0, 3.5, or 4.0 (Radiation therapy treatment planning system)
ARTG Number: 195288 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
A dose calculation error has been identified in RayStation versions 3.0. 3.5, and 4.0, when Elekta motorised wedges are used for a beam and the wedge angle differs from 60 degrees. The error is that the modified energy spectrum has been used not only for the wedged part of the beam but also for the open part of the wedged field. For all clinical cases investigated by the manufacturer, the deviations were at the most 3-5% in the clinically relevant areas of the plan. Deviations in the 10-12% range may occur in the buildup regions where dose calculations are generally considered approximate. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The issue will be resolved in RayStation patch 4.0.2 scheduled for market release in December 2013 and in all future releases. In the interim, workarounds for creating a beam with Elekta motorized wedge, without and with wedge optimization in described in the customer letter. |
| Contact Information |
02 9006 1662 - Emergo Australia |