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 |
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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