RayStation radiation therapy planning software density uncertainty calculation inconsistency
RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations affecting robust optimization and dose computation functions for proton and light ion treatment 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 with a computational inconsistency affecting treatment planning accuracy. The source reports no injuries, deaths, or illnesses. However, the defect involves a radiation therapy planning system where calculation errors in density uncertainty pose a significant risk of harm to patient treatment accuracy.
Plain-English summary
RayStation is a radiation therapy treatment planning system manufactured by RaySearch Laboratories AB and distributed worldwide, including throughout the United States and multiple international markets.
Affected versions include RayStation 9B through 10A with various service packs. The recall addresses an inconsistency in how the software handles density uncertainty in specific functions: Robust optimization, Robust evaluation, and Compute perturbed dose. This inconsistency occurs when the system uses a HU-to-mass density CT calibration curve and affects treatment planning for proton and light ion therapies.
Healthcare facilities and treatment planning centers using affected versions should contact RaySearch Laboratories AB for updated software that corrects this density uncertainty inconsistency.
The recalled product
- Product
- Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- dose-calculation-error
- density-uncertainty
- ct-calibration-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 (11)
- Lot Code: UDI: 0735000201026620191220
- 0735000201029720200310
- 0735000201030320200526
- 07350002010303
- 07350002010365 and 07350002010655 Serial Numbers: 9.1.0.933
- 9.2.0.483
- 10.0.0.1154
- 10.0.1.52 and 10.0.2.10 Software Revisions: RayStation 9B
- 9B Service Pack 1
- 10A
- 10A Service Pack 1 and 2 Expiration Date: 2025-06-16
Distribution
Distributed nationwide across the United States.
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