Raysearch Laboratories Ab recalls
14 official recalls and safety alerts involving Raysearch Laboratories Ab since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Raysearch Laboratories Ab or the relevant agency.
- 2026-07-08
USRAYSEARCH LABORATORIES AB recalls 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.
- 2026-01-28
- US
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025,…
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…
FDA · DeviceRAYSEARCH LABORATORIES ABRefer to the attached documents: Distribution list 167168 US - updated,…Official notice → - 2025-09-10
- US
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1,…
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL,…Official notice → - 2025-02-26
- US
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29,…
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…
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2024-05-08
- US
RAYSEARCH LABORATORIES AB recalls RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2024-04-17
- US
RAYSEARCH LABORATORIES AB recalls 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.
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2023-11-08
- US
RAYSEARCH LABORATORIES AB recalls RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical…
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…
- 2023-09-06
- US
RAYSEARCH LABORATORIES AB recalls RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows…
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
FDA · DeviceRAYSEARCH LABORATORIES ABUS Nationwide distribution in the state of TN.Official notice → - 2023-03-29
- US
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, 10.0.2, 10.1.0,…
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…
- 2022-07-27
- US
RAYSEARCH LABORATORIES AB recalls 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.
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide distribution - US Nationwide distribution in the state of TN and the…Official notice → - 2022-07-06
- US
RAYSEARCH LABORATORIES AB recalls 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…
FDA · DeviceRAYSEARCH LABORATORIES ABUS Nationwide distribution in the states of NJ and TX.Official notice → - 2022-04-06
- US
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, 4.7.2.5, 4.7.3.13,…
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…
- US
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, 6.3.0.6,…
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…
FDA · DeviceRAYSEARCH LABORATORIES ABUS Nationwide distribution in the states of AL, CA, FL, GA, IA, IL, MO, MS,…Official notice → - 2022-03-16
- US
RAYSEARCH LABORATORIES AB recalls 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…
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…