RAYSEARCH LABORATORIES AB
77 recalls on record · Latest: Jan 28, 2026
FDA Devices Moderate Jan 28, 2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 …
FDA Devices Moderate Jan 28, 2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStatio…
FDA Devices Moderate Jan 28, 2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 20…
FDA Devices Moderate Jan 28, 2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radi…
FDA Devices Moderate Jan 28, 2026
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation…
FDA Devices Moderate Jan 28, 2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A,…
FDA Devices Moderate Jan 28, 2026
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2,…
FDA Devices Moderate Jan 28, 2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Ra…
FDA Devices Moderate Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Softwar…
FDA Devices Moderate Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Ve…
FDA Devices Moderate Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Softwar…
FDA Devices Moderate Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software V…
FDA Devices Moderate Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2,…
FDA Devices Moderate Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Softwar…
FDA Devices Moderate Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Softwa…
FDA Devices Moderate Feb 26, 2025
Brand 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.…
FDA Devices Moderate Feb 26, 2025
Brand 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, 12.0.4.1…
FDA Devices Moderate Feb 26, 2025
Brand 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.…
FDA Devices Moderate Feb 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: …
FDA Devices Moderate Feb 26, 2025
Brand 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.…
FDA Devices Moderate Feb 26, 2025
Brand 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 Ver…
FDA Devices Moderate Feb 26, 2025
Brand 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.…
FDA Devices Moderate Feb 26, 2025
Brand 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:…
FDA Devices Moderate May 8, 2024
RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
FDA Devices Moderate May 8, 2024
RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
FDA Devices Moderate May 8, 2024
RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
FDA Devices Moderate May 8, 2024
RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
FDA Devices Moderate May 8, 2024
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
FDA Devices Moderate May 8, 2024
RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
FDA Devices Moderate May 8, 2024
RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
FDA Devices Moderate May 8, 2024
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
FDA Devices Moderate May 8, 2024
RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
FDA Devices Moderate Nov 8, 2023
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, …
FDA Devices Moderate 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, 10.0.2, 10.1.0, 10.1.1, 11.0.0,…
FDA Devices Moderate Jul 27, 2022
RayStation 9B SP1. For radiation treatment planning.
FDA Devices Moderate Apr 6, 2022
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, 4.7.4.4, 4.7…
FDA Devices Moderate 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 , 8.0.0.6 , 8.0.1.10 , 8…
FDA Devices Moderate May 26, 2021
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
FDA Devices Moderate 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 pack (10.0.1.52), 10B (10.1.0.613)
FDA Devices Moderate Mar 31, 2021
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
FDA Devices Moderate 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, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 -…
FDA Devices Moderate Sep 2, 2020
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and trea…
FDA Devices Moderate Jul 1, 2020
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9…
FDA Devices Moderate Jun 17, 2020
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer t…
FDA Devices Moderate Jun 17, 2020
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer …
FDA Devices Moderate Jun 17, 2020
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer tr…
FDA Devices Moderate Jun 17, 2020
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer tr…
FDA Devices Moderate Jun 17, 2020
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Devices Moderate Jun 17, 2020
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Devices Moderate Jun 17, 2020