Raysearch Laboratories Ab

Complete recall history across all FDA and CPSC categories — 113 total recalls

Raysearch Laboratories Ab appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (113)

FDA medical device enforcement actions by Raysearch Laboratories Ab. Showing most recent 50.

Date Product Reason Class
Nov 28, 2025 RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStatio... Potential for the invalidation for calculated radiation dose does not work as... Class II
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as... Class II
Nov 28, 2025 RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. S... Potential for the invalidation for calculated radiation dose does not work as... Class II
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as... Class II
Nov 28, 2025 RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12... Potential for the invalidation for calculated radiation dose does not work as... Class II
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as... Class II
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as... Class II
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as... Class II
Nov 28, 2025 Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... Potential for the invalidation for calculated radiation dose does not work as... Class II
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 2023B, ... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the inte... Class II
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 7, Soft... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the inte... Class II
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 12A, So... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the inte... Class II
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 10B, So... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the inte... Class II
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 6 Servi... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the inte... Class II
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 9B, Sof... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the inte... Class II
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 11A, So... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the inte... Class II
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 8B, Sof... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the inte... Class II
Aug 8, 2025 RayStation with the following product descriptions: 1. RayStation 11B, So... DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the inte... Class II
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions R... Class II
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions R... Class II
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions R... Class II
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions R... Class II
Jan 16, 2025 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions R... Class II
Jan 16, 2025 Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning Sys... Inconsistency in the use of Density uncertainty in the RayStation functions R... Class II
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions R... Class II
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions R... Class II
Jan 16, 2025 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions R... Class II
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions R... Class II
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions R... Class II
Mar 28, 2024 RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System. Potential for reported SSD to be too high. Class II
Mar 28, 2024 RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System. Potential for reported SSD to be too high. Class II
Mar 28, 2024 RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiati... Potential for reported SSD to be too high. Class II
Mar 28, 2024 RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning Sys... Potential for reported SSD to be too high. Class II
Mar 28, 2024 RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Pl... Potential for reported SSD to be too high. Class II
Mar 28, 2024 RayStation 7.0.0.19. Radiation Therapy Treatment Planning System. Potential for reported SSD to be too high. Class II
Mar 28, 2024 RayStation 15.0.0.430. Radiation Therapy Treatment Planning System. Potential for reported SSD to be too high. Class II
Mar 28, 2024 RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System. Potential for reported SSD to be too high. Class II
Mar 28, 2024 RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy ... Potential for reported SSD to be too high. Class II
Mar 28, 2024 RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System. Potential for reported SSD to be too high. Class II
Mar 28, 2024 RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Plannin... Potential for reported SSD to be too high. Class II
Mar 28, 2024 RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment ... Potential for reported SSD to be too high. Class II
Feb 23, 2024 RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A... A use error that has occurred with RayStation/RayPlan, where material overrid... Class II
Sep 12, 2023 RayCare 5B and 6A including service packs- An oncology information system use... An issue was found in RayCare 5B, 6A, including service packs, where values w... Class II
Jul 17, 2023 RayCare software, include version number 5A, 5B, 6A, including service packs-... An issue was found in Software RayCare 5A, 5B, 6A, including service packs, w... Class II
Feb 17, 2023 Raystation treatment planning system for radiation therapy, Model Numbers 9.0... It is possible to set a non-zero collimator angle in the Virtual Simulation m... Class II
Jun 10, 2022 RayStation 11B This notice concerns two issues found related to the display of Linear Energy... Class II
Jun 1, 2022 RayStation 9B SP1. For radiation treatment planning. An issue with propagation of treatment course information from RayStation wit... Class II
Dec 30, 2021 RayStation/RayPlan- designed for treatment planning and analysis of radiation... If a new primary image set is selected while the cine loop is running, the pr... Class II
Sep 22, 2021 RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations... An issue where the combined density in a dose grid voxel partially covered by... Class II
Sep 9, 2021 TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B... If the dynamic jaw mode is used and an optimization is continued after changi... Class II

View all 113 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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