RayStation software recall due to incorrect total dose display
RaySearch Laboratories is recalling RayStation software because the total dose display may be incorrect when using multiple plans in a treatment course.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, which typically corresponds to a High severity score when no hospitalizations or serious injuries are explicitly reported in the source text.
Plain-English summary
RaySearch Laboratories AB is recalling RayStation standalone software radiation therapy treatment planning systems. The affected models include 8A, 8B, 9A, 9B, 10A, and 10B, including some service packs. The recall is limited to specific software versions: 8.0.0.6, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, and 10.1.0.613.
The recall is due to a software defect where the 'Total dose' display in Dose tracking may be incorrect when using more than one plan in a treatment course. There may be a mismatch between the fractions that appear as selected in the Treatment course list and the fractions included in the dose summation. This issue only affects RayTreat users and only the 'Total dose' option; 'Accumulation' and other options in Dose tracking are correct.
The recall is classified as Class II by the FDA. The distribution pattern is listed as Domestic: TN. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
- 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 (11)
- Software version number: 8.0.0.6
- 8.0.1.10
- 8.1.0.47
- 8.1.1.8
- 8.1.2.5
- 9.0.0.113
- 9.1.0.933
- 9.2.0.483
- 10.0.0.1154
- 10.0.1.52
- 10.1.0.613
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · RAYSEARCH LABORATORIES AB
See all →- HighRayCare 2024A SP4 Oncology System Beam Set Delivery Note Data Loss
FDA (Devices) · 2026-07-08
- HighRayCare 2024A SP1 Oncology Information System Software Recall
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
- HighBlood transfusion filters recalled over unconfirmed sterility assurance before release
FDA (Devices) · 2026-01-28
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighRayStation Treatment Planning Software Recalled for Dose Calculation Errors
FDA (Devices) · 2020-02-05
- HighRayStation Radiation Therapy Software Recalled for Incorrect Dose Calculation
FDA (Devices) · 2023-07-05
- HighRayStation Radiation Therapy Software Recalled for Dose Calculation Accuracy Issues
FDA (Devices) · 2018-07-04
- HighRayStation 5.0 Radiation Therapy Software Recalled for Dose Display Error
FDA (Devices) · 2016-12-14
- HighRayStation Radiation Therapy Software Recalled for Potential Dose Errors
FDA (Devices) · 2014-04-09
- HighRayStation Radiation Therapy Software Recalled for Dose Calculation Errors
FDA (Devices) · 2018-08-01