RayStation Radiation Therapy Software Recalled for Display Errors
RaySearch Laboratories is recalling RayStation software due to a floating-point precision error that affects the display of isodose lines and color tables.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity. The issue is a display error in software that does not explicitly report injuries or hospitalizations, fitting the criteria for a moderate risk.
Plain-English summary
RaySearch Laboratories AB is recalling 20 units of RayStation Radiation Therapy Treatment Planning System software. The affected software versions are build numbers 4.7.0.15 and 4.7.1.10. The recall is due to an error caused by a floating-point precision problem.
This technical error causes issues with the display of isodose lines for dose and dose difference, as well as color tables for dose, dose difference, and PET images. The software is designed for treatment planning and analysis of radiation therapy, providing treatment unit set-up parameters and estimates of dose distributions.
The affected devices were distributed worldwide, including nationwide in the United States (specifically to the state of Washington) and in France, Sweden, Austria, Spain, Germany, Italy, the UK, and New Zealand. Users of the affected software should contact the manufacturer for further instructions regarding the recall.
The recalled product
- Product
- Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the…
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Category
- Medical Device — Software
- Affected units
- 20
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 (1)
- software build numbers are 4.7.0.15 or 4.7.1.10
Distribution
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