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Raysearch Laboratories Ab FDA Recalls
58 recalls on file across devices, 0 of them Class I and 51 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| RayCare 2024A SP4. Oncology Information Systems.Class IIMay 20, 2026Beam set delivery note issues in which there is potential da |
| RayCare 2024A SP1. Oncology Information Systems.Class IIMay 20, 2026Beam set delivery note issues in which there is potential da |
| Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStaClass IINov 28, 2025Potential for the invalidation for calculated radiation dose |
| Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStaClass IINov 28, 2025Potential for the invalidation for calculated radiation dose |
| RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy TreatmeClass IINov 28, 2025Potential for the invalidation for calculated radiation dose |
| Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 202Class IINov 28, 2025Potential for the invalidation for calculated radiation dose |
| RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStationClass IINov 28, 2025Potential for the invalidation for calculated radiation dose |
| Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software VersionClass IINov 28, 2025Potential for the invalidation for calculated radiation dose |
| RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RClass IINov 28, 2025Potential for the invalidation for calculated radiation dose |
| Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 SoftClass IINov 28, 2025Potential for the invalidation for calculated radiation dose |
| Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10BClass IINov 28, 2025Potential for the invalidation for calculated radiation dose |
| RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation Class IIAug 8, 2025DICOM SOP Instance UID and Series Instance UID from RayGatew |
| RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStatioClass IIAug 8, 2025DICOM SOP Instance UID and Series Instance UID from RayGatew |
| RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStatiClass IIAug 8, 2025DICOM SOP Instance UID and Series Instance UID from RayGatew |
| RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8Class IIAug 8, 2025DICOM SOP Instance UID and Series Instance UID from RayGatew |
| RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8AClass IIAug 8, 2025DICOM SOP Instance UID and Series Instance UID from RayGatew |
| RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStatioClass IIAug 8, 2025DICOM SOP Instance UID and Series Instance UID from RayGatew |
| RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2.Class IIAug 8, 2025DICOM SOP Instance UID and Series Instance UID from RayGatew |
| RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStatioClass IIAug 8, 2025DICOM SOP Instance UID and Series Instance UID from RayGatew |
| RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStaClass IIAug 8, 2025DICOM SOP Instance UID and Series Instance UID from RayGatew |
| Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1Class IIJan 16, 2025Inconsistency in the use of Density uncertainty in the RaySt |
| Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and Class IIJan 16, 2025Inconsistency in the use of Density uncertainty in the RaySt |
| Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0Class IIJan 16, 2025Inconsistency in the use of Density uncertainty in the RaySt |
| Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.Class IIJan 16, 2025Inconsistency in the use of Density uncertainty in the RaySt |
| Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13Class IIJan 16, 2025Inconsistency in the use of Density uncertainty in the RaySt |
| Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2Class IIJan 16, 2025Inconsistency in the use of Density uncertainty in the RaySt |
| Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.Class IIJan 16, 2025Inconsistency in the use of Density uncertainty in the RaySt |
| Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0Class IIJan 16, 2025Inconsistency in the use of Density uncertainty in the RaySt |
| Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.Class IIJan 16, 2025Inconsistency in the use of Density uncertainty in the RaySt |
| Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 SoftwClass IIJan 16, 2025Inconsistency in the use of Density uncertainty in the RaySt |
| Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.Class IIJan 16, 2025Inconsistency in the use of Density uncertainty in the RaySt |
| RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.Class IIMar 28, 2024Potential for reported SSD to be too high. |
| 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.Class IIMar 28, 2024Potential for reported SSD to be too high. |
| RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.Class IIMar 28, 2024Potential for reported SSD to be too high. |
| RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.Class IIMar 28, 2024Potential for reported SSD to be too high. |
| RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.Class IIMar 28, 2024Potential for reported SSD to be too high. |
| RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.Class IIMar 28, 2024Potential for reported SSD to be too high. |
| RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.Class IIMar 28, 2024Potential for reported SSD to be too high. |
| RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.Class IIMar 28, 2024Potential for reported SSD to be too high. |
| RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.Class IIMar 28, 2024Potential for reported SSD to be too high. |
| RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.Class IIMar 28, 2024Potential for reported SSD to be too high. |
| RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.Class IIMar 28, 2024Potential for reported SSD to be too high. |
| RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.Class IIMar 28, 2024Potential for reported SSD to be too high. |
| RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including somClass IIFeb 23, 2024A use error that has occurred with RayStation/RayPlan, where |
| RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as wClass IISep 12, 2023An issue was found in RayCare 5B, 6A, including service pack |
| RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to suppClass IIJul 17, 2023An issue was found in Software RayCare 5A, 5B, 6A, including |
| 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, 10Class IIFeb 17, 2023It is possible to set a non-zero collimator angle in the Vir |
| RayStation 11BClass IIJun 10, 2022This notice concerns two issues found related to the display |
| RayStation 9B SP1. For radiation treatment planning.Class IIJun 1, 2022An issue with propagation of treatment course information fr |
| RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6Class IIDec 30, 2021If a new primary image set is selected while the cine loop i |
| 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.Class IISep 22, 2021An issue where the combined density in a dose grid voxel par |
| TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7Class IISep 9, 2021If the dynamic jaw mode is used and an optimization is conti |
| RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combinatioClass IIJun 8, 2021Initial delivery positions will be set incorrectly when havi |
| RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.1Class IIApr 21, 2021Evaluation of a clinical goal for the voxelwise worst dose d |
| RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B inclClass IIApr 7, 2021When using more than one plan in a treatment course, the To |
| 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 packClass IIMar 25, 2021Flags edited in RayCare after a patient has been checked in |
| RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionalClass IIMar 3, 2021Patient related messages created in RayCare 3B, RayCare 4A w |
| 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 theClass IIFeb 22, 2021For some LINAC types, merging clinical beams with beams of a |