RayStation Treatment Planning Software Recalled for Dose Calculation Error
RaySearch Laboratories AB is recalling RayStation software versions 2.5.0.144 and 2.5.1.89 due to a dose calculation normalization issue. No patient mistreatment has occurred.
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 that could lead to incorrect dose calculations in radiation therapy, a high-risk scenario, but the source explicitly states that no patient mistreatment or incidents have occurred.
Plain-English summary
RaySearch Laboratories AB is recalling 19 units of RayStation Treatment Planning System software, specifically versions 2.5.0.144 and 2.5.1.89. The recall was initiated after the firm identified an issue with dose calculation normalization in unusual optimization cases. The affected software is designed for treatment planning and analysis of radiation therapy, providing set-up parameters and dose distribution estimates for intended users.
The distribution of the affected units is worldwide, including the United States (nationwide, with specific mentions of FL, MA, NJ, and NY) and Canada, Germany, the Netherlands, and Switzerland. The firm states that this problem has not caused any patient mistreatment or other incidents. However, users must be aware of this information to avoid incorrect dose calculations during treatment planning.
Intended users, who are clinically qualified radiation therapy staff, should be aware of this defect to ensure accurate treatment planning. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment pla
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- Affected units
- 19
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 · 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