RAYSEARCH LABORATORIES AB
36 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for RAYSEARCH LABORATORIES AB and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-10FDA-DeviceClass IIRayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Planning System.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
- 2025-09-10FDA-DeviceClass IIRayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Therapy Treatment Planning System.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
- 2025-09-10FDA-DeviceClass IIRayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Therapy Treatment Planning System.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
- 2025-09-10FDA-DeviceClass IIRayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Software Version: 12.0.4.12. 5. RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119. Product Description: Radiation Therapy Treatment Planning System.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
- 2025-09-10FDA-DeviceClass IIRayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Software Version: 11.0.4.15. Product Description: Radiation Therapy Treatment Planning System.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
- 2025-09-10FDA-DeviceClass IIRayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
- 2025-09-10FDA-DeviceClass IIRayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0.1.52. 5. RayStation 10A Service Pack 2, Software Version: 10.0.2.10. Product Description: Radiation Therapy Treatment Planning System.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
- 2025-09-10FDA-DeviceClass IIRayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113. 5. RayStation 9A Service Pack 1, Software Version: 9.0.1.142. Product Description: Radiation Therapy Treatment Planning System.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
- 2025-09-10FDA-DeviceClass IIRayStation 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 Description: Radiation Therapy Treatment Planning System.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
- 2025-02-26FDA-DeviceClass IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6
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.
- 2025-02-26FDA-DeviceClass IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3
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.
- 2025-02-26FDA-DeviceClass IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
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.
- 2025-02-26FDA-DeviceClass IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3
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.
- 2025-02-26FDA-DeviceClass IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
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.
- 2025-02-26FDA-DeviceClass IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 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.
- 2025-02-26FDA-DeviceClass IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3
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.
- 2025-02-26FDA-DeviceClass IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B 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.
- 2025-02-26FDA-DeviceClass IIBrand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2
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.
- 2025-02-26FDA-DeviceClass IIBrand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A 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.
- 2025-02-26FDA-DeviceClass IIBrand 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.
- 2024-05-08FDA-DeviceClass IIRayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceClass IIRayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceClass IIRayStation 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.
- 2024-05-08FDA-DeviceClass IIRayStation 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.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceClass IIRayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceClass IIRayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceClass IIRayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceClass IIRayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceClass IIRayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceClass IIRayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
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