FDA recall record · openFDA
RAYSEARCH LABORATORIES AB
45 FDA recalls on record (2023–2025) — 45 device. 45 still ongoing.
0
Class I (most serious)
45
Class II
0
Class III
45
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Potential for reported SSD to be too high. 12
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and C 11
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest ( 9
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed 9
It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the use 1
Recalls
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RaySta Class II 2025-11-28 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version Class II 2025-11-28 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0 Class II 2025-01-16 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RaySta Class II 2025-11-28 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12. Class II 2025-01-16 RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStatio Class II 2025-08-08 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 202 Class II 2025-11-28 RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8 Class II 2025-08-08 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1 Class II 2025-01-16 RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStatio Class II 2025-08-08 RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation Class II 2025-08-08 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and Class II 2025-01-16 RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, R Class II 2025-11-28 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Soft Class II 2025-11-28 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2 Class II 2025-01-16 RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. Class II 2025-08-08 RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation Class II 2025-11-28 Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0 Class II 2025-01-16 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9. Class II 2025-01-16 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0. Class II 2025-01-16 RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStatio Class II 2025-08-08 RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStati Class II 2025-08-08 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B Class II 2025-11-28 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13 Class II 2025-01-16 RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatme Class II 2025-11-28 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5. Class II 2025-01-16 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Softw Class II 2025-01-16 RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A Class II 2025-08-08 RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RaySta Class II 2025-08-08 RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System. Class II 2024-03-28 RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System. Class II 2024-03-28 RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System. Class II 2024-03-28 RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System. Class II 2024-03-28 RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System. Class II 2024-03-28 RayStation 15.0.0.430. Radiation Therapy Treatment Planning System. Class II 2024-03-28 RayStation 7.0.0.19. Radiation Therapy Treatment Planning System. Class II 2024-03-28 RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System. Class II 2024-03-28 RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System. Class II 2024-03-28 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 II 2024-03-28 RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System. Class II 2024-03-28 RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System. Class II 2024-03-28 RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including som Class II 2024-02-23 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 Class II 2023-02-17 RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as w Class II 2023-09-12 RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to supp Class II 2023-07-17
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.