52 results · 43ms · Sources: EU EUDAMED, US FDA

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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.

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024

RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024

RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024

RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·February 23, 2024

RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·July 17, 2023

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: RayStation 6 Service Pack 1, 2 and 3

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·January 16, 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: RayStation 10B and 10B Service Pack 1

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·January 16, 2025

RayStation 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.

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·August 8, 2025

RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024

RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·July 29, 2020

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 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·January 16, 2025

RayStation 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.

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·August 8, 2025

RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024

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, 4.7.5.4 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

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·January 16, 2025

Brand 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

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·January 16, 2025

RayStation 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.

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·August 8, 2025

RayStation 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.

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·August 8, 2025

RayStation 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.

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·August 8, 2025

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, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·November 28, 2025

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, 9.2

FDA Recall
Open, Classified ·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 26, 2020