Medical device manufacturer, RaySearch Laboratories AB (publ), has issued a medical device safety alert concerning its RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, 10A, 10B, including some of the service packs.
According to the manufacturer, this safety alert concerns an issue found with the Merge beams functionality in RayStation/RayPlan on 3-dimensional conformal radiotherapy (3D-CRT) and intensity-modulated radiotherapy (IMRT) photon planning with certain Linear Accelerator (LINAC) models and settings. It is reported that merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams functionality can be used in manual "Merge beams" in the 3D-CRT module, in scripting when using the action MergeBeamSegments, or as part of the Automated breast planning.
According to the manufacturer's Health Hazard Evaluation, if a clinical decision is based on an approximate dose that is incorrectly marked as clinical, this could lead to the approval of an inappropriate dose plan. This could lead to local over-dose in a risk organ from allowing too high of a dose in the treatment plan or underdosage to the target.
The manufacturer advises users to take note of the error and its workaround when using the affected device. It is stated that the next version of RayStation/RayPlan that will resolve the issue is scheduled for market release in May 2021.
According to the manufacturer, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 24 February 2021