Data / Medical devices / Sweden / RaySearch Laboratories AB (publ)
RaySearch Laboratories AB (publ): FDA-registered device maker in Stockholm, Sweden, 12 510(k) clearances
RaySearch Laboratories AB (publ) is registered with the FDA (registration 3007774465) in Stockholm, Sweden. It lists 1 device type. The FDA files 12 510(k) clearances under its listings, the newest dated April 17, 2025. 59 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007774465
- Address
- Eugeniavaegen 18C, Stockholm, Sweden, 11368
- Owner or operator
- RaySearch Laboratories AB (publ) (10029973)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 23, 2017
- Registered through
- 2026
- Brand names listed
- RayCare 2024A SP1, RayCare 3.1, RayPlan 10A, RayPlan 10B, RayPlan 11A, RayPlan 11B, RayPlan 12A, RayPlan 2023B and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 17, 2025 | K242992 | RayCare (2024A SP1) | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| April 4, 2025 | K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| March 29, 2023 | K222312 | RayStation 12A | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| April 15, 2022 | K220141 | RayStation 11B | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| September 8, 2021 | K211867 | RayStation 11.0 | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| June 29, 2021 | K210645 | RayStation 10.1 | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| September 24, 2020 | K200569 | RayStation | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| June 10, 2020 | K200487 | RayCare 3.1 | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| June 19, 2019 | K190387 | RayStation | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| April 25, 2018 | K180379 | RayStation 7 | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| June 27, 2017 | K171536 | RayStation | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| March 2, 2017 | K170355 | RayStation 6 | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 20, 2026 | 99141 | Class II | Ongoing | RayCare 2024A SP1. Oncology Information Systems. | Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change. | accessdata.fda.gov |
| November 28, 2025 | 98117 | Class II | Ongoing | RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removin | accessdata.fda.gov |
| August 8, 2025 | 97400 | Class II | Ongoing | RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Descript | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. | accessdata.fda.gov |
| January 16, 2025 | 96156 | Class II | Ongoing | Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1 | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs. | accessdata.fda.gov |
| March 28, 2024 | 94388 | Class II | Ongoing | RayStation 7.0.0.19. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | accessdata.fda.gov |
| February 23, 2024 | 94153 | Class II | Ongoing | RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs. | A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant. | accessdata.fda.gov |
| September 12, 2023 | 93139 | Class II | Ongoing | RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build | An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with single- or multi-selectable values. | accessdata.fda.gov |
| July 17, 2023 | 92777 | Class II | Ongoing | RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for | An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances | accessdata.fda.gov |
| February 17, 2023 | 91867 | Class II | Ongoing | Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4 | It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regard | accessdata.fda.gov |
| June 10, 2022 | 90505 | Class II | Terminated | RayStation 11B | This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam. | accessdata.fda.gov |
| June 1, 2022 | 90498 | Class II | Terminated | RayStation 9B SP1. For radiation treatment planning. | An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare. | accessdata.fda.gov |
| December 30, 2021 | 89631 | Class II | Ongoing | RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, | If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running | accessdata.fda.gov |
| September 22, 2021 | 89800 | Class II | Ongoing | RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2 | An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated | accessdata.fda.gov |
| September 9, 2021 | 89788 | Class II | Terminated | TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 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, | If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning | accessdata.fda.gov |
| June 8, 2021 | 88258 | Class II | Terminated | RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.93 | Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point. | accessdata.fda.gov |
| April 21, 2021 | 87977 | Class II | Terminated | RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 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 or 1 | Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices is d 1 mm, present in RayStation/RayPlan versions from 6 up to 10A. | accessdata.fda.gov |
| April 7, 2021 | 87868 | Class II | Terminated | RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs | When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accu | accessdata.fda.gov |
| March 25, 2021 | 87666 | Class II | Ongoing | RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613) | Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat. | accessdata.fda.gov |
| March 3, 2021 | 87471 | Class II | Ongoing | RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care. | Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later | accessdata.fda.gov |
| February 22, 2021 | 87797 | Class II | Terminated | RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system | For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate | accessdata.fda.gov |
| November 11, 2020 | 86832 | Class II | Terminated | RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7 | Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect. | accessdata.fda.gov |
| October 8, 2020 | 86668 | Class II | Terminated | RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy a | If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI. | accessdata.fda.gov |
| July 29, 2020 | 86249 | Class II | Ongoing | RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. | When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available. | accessdata.fda.gov |
| May 26, 2020 | 85796 | Class II | Ongoing | RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2 | It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat. | accessdata.fda.gov |
| May 18, 2020 | 85723 | Class II | Terminated | RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. | accessdata.fda.gov |
| March 4, 2020 | 85255 | Class II | Ongoing | RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. B | Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. I | accessdata.fda.gov |
| February 20, 2020 | 85065 | Class II | Terminated | RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system | There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect. | accessdata.fda.gov |
| December 19, 2019 | 84705 | Class II | Terminated | RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0. | Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of o | accessdata.fda.gov |
| November 18, 2019 | 84508 | Class II | Terminated | RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning an | Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported. | accessdata.fda.gov |
| November 12, 2018 | 81693 | Class II | Terminated | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A | Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system. | accessdata.fda.gov |
| September 21, 2018 | 81269 | Class II | Terminated | RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system. | Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7. | accessdata.fda.gov |
| June 29, 2018 | 80459 | Class II | Terminated | RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) Produ | If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to potentially significant overdosage at delivery. The user must be aware of the issue to avoid incorrect dose calculations during treatment planning. | accessdata.fda.gov |
| June 6, 2018 | 80515 | Class II | Terminated | RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of | The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Model | accessdata.fda.gov |
| March 28, 2018 | 80252 | Class II | Terminated | RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans prov | The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning. | accessdata.fda.gov |
| January 26, 2018 | 79582 | Class II | Terminated | Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130 | Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient. | accessdata.fda.gov |
| November 20, 2017 | 83152 | Class II | Terminated | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6). Intended Use: software system designed for treatment planning and analy | When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong | accessdata.fda.gov |
| July 17, 2017 | 78900 | Class II | Terminated | RayStation Product Usage: 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 distributions expected | For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient. | accessdata.fda.gov |
| January 18, 2017 | 76342 | Class II | Terminated | Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parame | An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board (graphics card) an erroneous calculation may be allowed. | accessdata.fda.gov |
| November 9, 2016 | 75731 | Class II | Terminated | RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide | Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. For treatment plans with a combination of range shifter, large air gap and beams that enter the patient surface at an oblique angle, the dose calculation accuracy may be less than expected. | accessdata.fda.gov |
| October 11, 2016 | 75633 | Class II | Terminated | Radiation Therapy Treatment Planning System 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 a | An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT set exists in another case, the dose display may be incorrect. When the error occurs, the display of dose in patient views, | accessdata.fda.gov |
| September 1, 2016 | 75173 | Class II | Terminated | RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The | RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The correction concerns two issues found with the dose calculation when using a region of interest (ROI) of type Fixation or Support with material override within the patient outline (External ROI) in RayStation 2.5, | accessdata.fda.gov |
| July 1, 2016 | 74618 | Class II | Terminated | RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provi | An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. -- To the best of the firm's knowledge, the issue has not c | accessdata.fda.gov |
| May 30, 2016 | 74750 | Class II | Terminated | Radiation Therapy Treatment Planning System, Model 5.0 | For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics. | accessdata.fda.gov |
| February 10, 2016 | 73575 | Class II | Terminated | RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy. | A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized with the stored data if simultaneously right clicking, pressing Ctrl-S or Ctrl-Z while the left mouse button is held down. This bug does not affect dose computations, whic | accessdata.fda.gov |
| May 29, 2015 | 71477 | Class II | Terminated | Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and est | An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images | accessdata.fda.gov |
| May 27, 2015 | 71414 | Class II | Terminated | RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy. | Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and po | accessdata.fda.gov |
| May 8, 2015 | 71289 | Class II | Terminated | 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 treatm | RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing. | accessdata.fda.gov |
| March 4, 2015 | 70686 | Class II | Terminated | RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw | An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics. | accessdata.fda.gov |
| April 25, 2014 | 68162 | Class II | Terminated | RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy. | This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material overr | accessdata.fda.gov |
| February 14, 2014 | 67535 | Class II | Terminated | RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0. | RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image. | accessdata.fda.gov |
| February 6, 2014 | 67511 | Class II | Terminated | RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software | RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy. | accessdata.fda.gov |
| February 6, 2014 | 67504 | Class II | Terminated | RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy. | Potential for dose errors due to software program errors. | accessdata.fda.gov |
| October 23, 2013 | 66600 | Class II | Terminated | Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0 | Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees. | accessdata.fda.gov |
| February 15, 2013 | 65136 | Class II | Terminated | RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analy | Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning. | accessdata.fda.gov |
| May 9, 2012 | 62967 | Class II | Terminated | 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 | The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the un | accessdata.fda.gov |
| December 6, 2011 | 61269 | Not yet classified | Terminated | RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. Designed for treatment planning and analysis of radiation therapy. | An issue was found with the dose calculation in the RayStation 2.0, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient. | accessdata.fda.gov |
| October 19, 2011 | 60409 | Not yet classified | Terminated | RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. RayStation is a software system designed for treatment planning and analysis of radiation thera | The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient. | accessdata.fda.gov |
| October 10, 2011 | 63186 | Class II | Terminated | SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on | This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior | accessdata.fda.gov |
| May 30, 2011 | 63110 | Class II | Terminated | The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the buil | This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation | accessdata.fda.gov |
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Updated July 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.