RayStation 8A Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 8A software due to a defect in dose calculation algorithms that may underestimate radiation dose.
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 radiation dosing, representing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
RaySearch Laboratories AB is recalling RayStation 8A software (UDI # 07350002010112, Build number 8.0.0.61) used for radiation therapy and medical oncology. The recall was initiated after a software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms.
The defect could result in a local underestimation of the expected radiation dose administered to patients. The software was distributed nationwide in the United States, including in Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.
Healthcare providers and facilities using this software should contact RaySearch Laboratories for further instructions on how to address the defect and ensure patient safety.
The recalled product
- Product
- RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Manufacturer
- RAYSEARCH LABORATORIES AB
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)
- UDI # 07350002010112 Build number: 8.0.0.61
Distribution
Part of a larger recall action
This product is one of 15 recalled by RAYSEARCH LABORATORIES AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →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