Medical device manufacturer, RaySearch Laboratories, issued a medical device safety alert concerning its RayStation, RayPlan [All versions: 2-11A].
According to the manufacturer, a customer noticed a difference in electron dose depending on whether a bolus was delineated inside or outside the patient external contour. Their investigation showed that there was a limitation in the discretization of certain Regions of Interest (ROI). When combining densities from the CT values inside the External ROI with densities from an ROI of type Bolus, Support or Fixation, the combined densities might be wrong, leading to situations where accuracy of the dose calculation might be lower than otherwise expected. In the event that an inappropriate treatment plan was approved for treatment due to this error, this could result in a local over dosage in a risk organ or local under dosage in a target. According to the manufacturer, there has been no serious adverse event
The manufacturer suggested the following corrective actions:
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 28 Sept 2021