Recall archive
53 recalls · page 1 of 3
Reported Jul 8, 2026
RayCare 2024A SP1. Oncology Information Systems.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 28, 2026
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2025
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for…
10 more products in this recall
FDA (openFDA device enforcement)
Reported May 8, 2024
RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Potential for reported SSD to be too high.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2024
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer…
FDA (openFDA device enforcement)
Reported Nov 8, 2023
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Sep 6, 2023
RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient)…
FDA (openFDA device enforcement)
Reported Mar 29, 2023
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,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jul 27, 2022
RayStation 9B SP1. For radiation treatment planning.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows,…
FDA (openFDA device enforcement)
Reported Jul 6, 2022
RayStation 11B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First,…
FDA (openFDA device enforcement)
Reported Apr 6, 2022
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,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 16, 2022
RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 ,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Aug 4, 2021
RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
FDA (openFDA device enforcement)
Reported Jun 16, 2021
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 ,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an…
FDA (openFDA device enforcement)
Reported May 26, 2021
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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 21, 2021
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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
FDA (openFDA device enforcement)
Reported Mar 31, 2021
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
FDA (openFDA device enforcement)
Reported Dec 23, 2020
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.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Dec 2, 2020
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,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Sep 2, 2020
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jul 1, 2020
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jun 17, 2020
RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 1, 2020
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,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Raysearch Laboratories Ab
Matched: Brand — Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will…
FDA (openFDA device enforcement)
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