RayStation radiation therapy software recall for density calculation inconsistency
RayStation treatment planning software versions 4.5-2024B contain a calculation error in density uncertainty functions affecting proton and light ion treatment plans. The error could lead to incorrect dose calculations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a software calculation error in a medical device used for radiation therapy planning. While the error creates a significant risk of harm through incorrect dose calculation, no illnesses or injuries have been reported. The classification as High reflects the risk-of-harm nature of the product without documented patient harm.
Plain-English summary
RayStation is a software system used by hospitals and cancer treatment centers to plan radiation therapy doses for cancer patients. The software versions affected by this recall (4.5 through 2024B, including some service packs) contain an inconsistency in how they handle density uncertainty when using HU-to-mass density CT calibration curves in three key functions: Robust optimization, Robust evaluation, and Compute perturbed dose.
This inconsistency affects treatment plans for proton and light ion therapies. Because radiation therapy dose calculations must be precise to safely treat patients, an error in density calculations could result in doses that differ from what the radiation oncologist intended.
RaySearch Laboratories AB is the manufacturer. The software has been distributed worldwide including throughout the United States, Canada, Australia, and multiple European and Asian countries. Healthcare facilities using affected versions of RayStation should contact the manufacturer for guidance and software updates.
The recalled product
- Product
- Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- calculation-error
- dose-miscalculation
- software-bug
Distribution
Distributed nationwide across the United States.
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