Medical device recall: RayStation radiation therapy software dose calculation inconsistency
RayStation radiation therapy treatment planning software contains an inconsistency in density uncertainty calculations that may affect dose accuracy for proton and light ion treatments. The issue affects systems using HU-to-mass density CT calibration curves from RayStation versions 4.5 through 2024B.
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 Class II FDA recall affecting medical device software with no reported injuries or illnesses documented. The hazard is a calculation inconsistency affecting radiation therapy dose accuracy, representing a risk-of-harm scenario where injury has not yet been reported, warranting a score of 3 (High) per the severity rubric.
Plain-English summary
RayStation is a radiation therapy treatment planning system developed by RaySearch Laboratories AB and distributed worldwide. The software is used to calculate and optimize radiation doses for cancer treatment, particularly for proton and light ion therapies.
A Class II recall has been issued due to an inconsistency in how the software handles density uncertainty in three functions: Robust Optimization, Robust Evaluation, and Compute Perturbed Dose. This issue affects treatment plans that use HU-to-mass density CT calibration curves from RayStation versions 4.5 through 2024B, including certain service packs. The inconsistency in density uncertainty calculations could impact the accuracy of dose calculations for affected treatment plans.
The affected software has been distributed worldwide, including throughout the United States and in Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain, Switzerland, Taiwan, Thailand, and the United Kingdom.
The recalled product
- Product
- Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- dose-calculation-error
- density-uncertainty
Distribution
Distributed nationwide across the United States.
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