RayStation 4.7.1 Radiation Therapy Software Recalled for Algorithm Error
RaySearch Laboratories is recalling RayStation 4.7.1 software due to an algorithm error that reverses contraction distances in radiation therapy planning.
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: The recall involves a high-risk medical device software defect that could lead to incorrect treatment planning, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
RaySearch Laboratories AB is recalling 126 programs of RayStation 4.7, version 4.7.1, a Radiation Therapy Treatment Planning System. The recall involves software build numbers 4.7.1.10 used with Structure Definition or Automatic Breast Planning features.
The recall is due to an issue with the algorithm for ROI (Region of Interest) contraction. When non-uniform contraction distances are used, the tool incorrectly interprets the input distances. Specifically, the right distance is interpreted as left, inferior as superior, and posterior as anterior. This error occurs because the six input distances are pairwise reversed.
The affected software was distributed in Colorado, Illinois, Michigan, North Carolina, Ohio, Tennessee, and Washington. Users of this specific software version should contact the manufacturer for further instructions on correcting the planning parameters.
The recalled product
- Product
- RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Affected units
- 126
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 4.7.1.10
Distribution
Related recalls
Same manufacturer · RAYSEARCH LABORATORIES AB
See all →- HighRayCare 2024A SP1 Oncology Information System Software Recall
FDA (Devices) · 2026-07-08
- HighRayCare 2024A SP4 Oncology System Beam Set Delivery Note Data Loss
FDA (Devices) · 2026-07-08
- HighRayStation 2024A treatment planning recalled over dose that fails to invalidate
FDA (Devices) · 2026-01-28
- HighRayStation 2023B and 2024A recalled over dose that fails to invalidate
FDA (Devices) · 2026-01-28
- HighRayStation v2025 treatment planning recalled over dose that fails to invalidate
FDA (Devices) · 2026-01-28
Same hazard · algorithm error
See all →- High