Skip to main content
All Recalls

Every Raysearch Laboratories Ab Recall

Sorted by most recent. Click any recall for full details.

72 recalls
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RaySt...
Medical Devices·0 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023...
Medical Devices·119 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, R...
Medical Devices·0 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Descr...
Medical Devices·0 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
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...
Medical Devices·22 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: Ray...
Medical Devices·8 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStat...
Medical Devices·10 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pac...
Medical Devices·6 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1,...
Medical Devices·2 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pac...
Medical Devices·3 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1...
Medical Devices·26 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Ser...
Medical Devices·0 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pac...
Medical Devices·3 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pa...
Medical Devices·13 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
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...
Medical Devices·6 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
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....
Medical Devices·5 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
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....
Medical Devices·1 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Softwa...
Medical Devices·0 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
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...
Medical Devices·0 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
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 ...
Medical Devices·0 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1...
Medical Devices·1 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
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 Softw...
Medical Devices·1 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Medical Devices·128 affected·Mar 28, 2024
High RiskFDA
Raysearch Laboratories Ab
RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
Medical Devices·5 affected·Mar 28, 2024
High RiskFDA
Raysearch Laboratories Ab
RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
Medical Devices·63 affected·Mar 28, 2024
High RiskFDA
Raysearch Laboratories Ab
RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
Medical Devices·10 affected·Mar 28, 2024
High RiskFDA
Raysearch Laboratories Ab
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
Medical Devices·9 affected·Mar 28, 2024
High RiskFDA
Raysearch Laboratories Ab
RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
Medical Devices·3 affected·Mar 28, 2024
High RiskFDA
Raysearch Laboratories Ab
RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
Medical Devices·14 affected·Mar 28, 2024
High RiskFDA
Raysearch Laboratories Ab
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Medical Devices·213 affected·Mar 28, 2024
High RiskFDA
Raysearch Laboratories Ab
RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Medical Devices·18 affected·Mar 28, 2024
High RiskFDA
Raysearch Laboratories Ab
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical i...
Medical Devices·2 affected·Sep 12, 2023
High RiskFDA
Raysearch Laboratories Ab
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....
Medical Devices·10,770 affected·Feb 17, 2023
High RiskFDA
Raysearch Laboratories Ab
RayStation 9B SP1. For radiation treatment planning.
Medical Devices·1 affected·Jun 1, 2022
High RiskFDA
Raysearch Laboratories Ab
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...
Medical Devices·13,722 affected·Apr 21, 2021
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some servic...
Medical Devices·0 affected·Apr 7, 2021
High RiskFDA
Raysearch Laboratories Ab
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...
Medical Devices·1 affected·Mar 25, 2021
High RiskFDA
Raysearch Laboratories Ab
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering c...
Medical Devices·1 affected·Mar 3, 2021
High RiskFDA
Raysearch Laboratories Ab
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,...
Medical Devices·2,768 affected·Oct 8, 2020
High RiskFDA
Raysearch Laboratories Ab
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, plann...
Medical Devices·0 affected·Jul 29, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1,...
Medical Devices·12 affected·May 26, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to ...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to a...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to a...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer tre...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer tre...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to...
Medical Devices·0 affected·May 18, 2020