RayStation 6 Service Pack 1 Radiation Therapy Software Recall
RaySearch Laboratories is recalling RayStation 6 Service Pack 1 software due to a calculation error 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 risk-of-harm product (radiation therapy software) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
RaySearch Laboratories AB is recalling RayStation 6 Service Pack 1, a software product used for radiation therapy and medical oncology. The recall is due to a software error identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms.
The error could result in a local underestimation of the expected dose during treatment administration. The affected software has UDI numbers 07350002010037 and 07350002010082, with build number 6.1.1.2.
The product 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. Users of this software should contact the manufacturer for further instructions regarding the recall.
The recalled product
- Product
- RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
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 (2)
- UDI #s 07350002010037
- 07350002010082 Build number: 6.1.1.2
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