Radiation Therapy Planning Software Correction for Density Uncertainty in Dose Calculations
RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations within dose planning functions affecting proton and light ion treatments in 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 FDA Class II medical device recall involving a risk-of-harm product (radiation therapy planning software). The density uncertainty inconsistency could affect dose calculation accuracy in treatment plans. No injuries or illnesses are reported in the source text.
Plain-English summary
RayStation is a radiation therapy treatment planning system manufactured by RaySearch Laboratories AB.
An inconsistency has been identified in the use of density uncertainty within RayStation functions used for robust optimization, robust evaluation, and computing perturbed dose calculations. This affects proton and light ion treatment planning in versions 4.5 through 2024B, including some service packs.
The software has been distributed worldwide, including throughout the United States and internationally to treatment centers in Australia, Canada, China, and numerous European and Asian countries.
The recalled product
- Product
- Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- dose-calculation-error
- treatment-planning-error
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 (5)
- Lot Code: UDI: 0735000201006820171130
- 0735000201011220180608 and 0735000201013620180928 GTIN: 07350002010068
- 07350002010112 and 07350002010136 Serial Numbers: 7.0.0.19
- 8.0.0.61 and 8.0.1.10 Software Revision: RayStation 7
- 8A and 8A Service Pack 1 Expiration Date: 2023-10-04
Distribution
Distributed nationwide across the United States.
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