Radiation Therapy Planning System Density Calculation Inconsistency in RayStation
RayStation radiation therapy planning software versions 4.5 through 2024B contain an inconsistency in how density uncertainty is handled in dose calculation functions for proton and light ion therapy plans.
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: FDA Class II medical device recall involving a radiation therapy treatment planning system with a documented inconsistency in density uncertainty handling. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, yielding a High severity score.
Plain-English summary
RayStation is a radiation therapy treatment planning system developed by RaySearch Laboratories AB and used to create customized radiation therapy plans for cancer patients. The FDA has classified a recall of versions 4.5 through 2024B as Class II due to an inconsistency in how the software handles density uncertainty in certain treatment planning functions.
The inconsistency affects the Robust optimization, Robust evaluation, and Compute perturbed dose functions specifically when used with proton and light ion therapy treatment plans that use HU-to-mass density CT calibration curves. The affected software versions are identified by specific serial numbers and UDI codes listed in the recall notice.
The software has been distributed worldwide to healthcare facilities in the US and internationally, including Australia, Canada, France, Germany, Japan, and the United Kingdom. Facilities using affected versions should contact RaySearch Laboratories AB for information about software updates and guidance on validating existing treatment plans.
The recalled product
- Product
- Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- dose-calculation-error
- density-uncertainty-inconsistency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot Code: UDI: 0735000201038920210518
- 0735000201043320210610
- 0735000201044020210916 and 0735000201063120220616 GTIN: 07350002010389
- 07350002010433
- 07350002010440 and 07350002010631 Serial Numbers: 11.0.0.951
- 11.0.1.29
- 2 and 3 Expiration Date: 2027-06-22
Distribution
Distributed nationwide across the United States.
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