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RAYSEARCH LABORATORIES AB Recalls
115 recalls on record · September 12, 2012 to July 8, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 26, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0
Hazard: 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.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
May 8, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
Hazard: Potential for reported SSD to be too high.
April 17, 2024Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including som
Hazard: A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
November 8, 2023Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as w
Hazard: 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.
September 6, 2023Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to supp
Hazard: 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
March 29, 2023Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls 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
Hazard: 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, regardless of the selected collimator angle.
July 27, 2022Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 9B SP1. For radiation treatment planning.
Hazard: 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.
July 6, 2022Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 11B
Hazard: 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.
April 6, 2022Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls 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.
Hazard: 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
April 6, 2022Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls 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
Hazard: 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
March 16, 2022Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6
Hazard: 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
August 4, 2021Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combinatio
Hazard: Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
June 16, 2021Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.1
Hazard: 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.
May 26, 2021Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B incl
Hazard: 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. Accumulation and other options in Dose tracking are correct.
May 26, 2021Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls 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
Hazard: 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 dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.
April 21, 2021Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls 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
Hazard: Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
March 31, 2021Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professional
Hazard: Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
December 23, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls 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. RayS
Hazard: 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.
December 2, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls 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.
Hazard: 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.