RaySearch RayStation Software Recalled for Dose Calculation Errors
RaySearch Laboratories AB is recalling RayStation software versions 2.5 through 4.0 due to dose calculation issues in specific VMAT 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: The recall involves a medical device software defect affecting radiation therapy dose calculations, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
RaySearch Laboratories AB is recalling RaySearch RayStation 2.5, 3.0, 3.5, and 4.0 software systems. The recall involves 539 domestic units distributed nationwide in the United States. The affected software versions include specific build numbers such as 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, and 4.0.3.4.
The recall was initiated because the manufacturer became aware of an issue with dose calculation for some imported VMAT plans where control points are defined with wide gantry angle spacing. RayStation is a software system designed for treatment planning and analysis of radiation therapy, providing treatment unit set-up parameters and estimates of dose distributions.
The intended users of this software are clinically qualified radiation therapy staff trained in using the system. The source text does not specify further instructions for consumers or healthcare providers beyond the identification of the affected software versions and the nature of the defect.
The recalled product
- Product
- RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: 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 distri
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- Affected units
- 539
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 (8)
- Software Version (Build numbers) 2.5.1.89
- 3.0.0.251
- 3.5.0.16
- 3.5.1.6
- 4.0.0.14
- 4.0.1.4
- 4.0.2.9
- or 4.0.3.4
Distribution
Distributed nationwide across the United States.
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 · dose calculation error
See all →- HighRadiation Therapy Planning System Density Calculation Inconsistency in RayStation
FDA (Devices) · 2025-02-26
- HighRayStation radiation therapy planning software density uncertainty calculation inconsistency
FDA (Devices) · 2025-02-26
- HighMedical device recall: RayStation radiation therapy software dose calculation inconsistency
FDA (Devices) · 2025-02-26
- HighRayStation Radiation Therapy Planning Software Recall for Density Calculation Inconsistency
FDA (Devices) · 2025-02-26
- HighRadiation Therapy Planning Software Correction for Density Uncertainty in Dose Calculations
FDA (Devices) · 2025-02-26