RAYSEARCH LABORATORIES AB recalls
Every recall we track for RAYSEARCH LABORATORIES AB — 95 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from RAYSEARCH LABORATORIES AB more than doubled in 2025 (29, up from 13 in 2024).
All FDA recall records for RAYSEARCH LABORATORIES AB since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 1 | 0 | 2 |
| 2018 | 0 | 3 | 3 | 0 | 6 |
| 2019 | 0 | 1 | 1 | 0 | 2 |
| 2020 | 0 | 0 | 27 | 0 | 27 |
| 2021 | 0 | 1 | 6 | 2 | 9 |
| 2022 | 0 | 0 | 2 | 0 | 2 |
| 2023 | 0 | 0 | 3 | 0 | 3 |
| 2024 | 0 | 0 | 12 | 1 | 13 |
| 2025 | 0 | 1 | 24 | 4 | 29 |
| 2026 (to date) | 0 | 0 | 2 | 0 | 2 |
Most common reasons for RAYSEARCH LABORATORIES AB recalls
What to do if you have a recalled RAYSEARCH LABORATORIES AB product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All RAYSEARCH LABORATORIES AB recalls
37 shown- Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayCare 2024A SP1. Oncology Information Systems.
RaySearch Laboratories recalls RayCare 2024A SP1 software version 8.0.1.60193 due to potential data loss if beam set delivery notes are modified during treatment sessions.
RaySearch LaboratoriesMay 20, 2026 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version:
RayStation v2025 and v2025 SP1 software versions 17.0.0 and 17.0.1 may cause radiation dose calculations to fail for certain treatment areas. Affected users should contact RaySearch Laboratories for updates.
RayStationNov 28, 2025 - UnratedMedical device
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B
RaySearch recalls RayStation software versions 12.0.0.932 and others due to potential duplicate DICOM identifiers, which could cause treatment errors in radiation therapy. Affected users should contact RaySearch for updates.
RaySearchAug 8, 2025 - UnratedMedical device
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951,
RaySearch Laboratories recalls RayStation software versions 11A and 11A Service Packs 1-3 with model numbers 1.0.0.951 and others due to density uncertainty errors in radiation therapy planning.
RaySearch LaboratoriesJan 16, 2025 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
RaySearch Laboratories recalls specific versions of RayStation radiation therapy software due to potential for reported SSD values to be too high. Affected users should contact the company for details.
RaySearch LaboratoriesMar 28, 2024 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including
RaySearch recalls software versions 8B through 2024A due to risk of incorrect silicone implant material selection in treatment planning.
RaySearchFeb 23, 2024 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as
RaySearch Laboratories recalls RayCare 5B and 6A software versions where documents in read-only state may not display correctly when opened outside Documents workspace. Affected units include specific build numbers and service packs.
RaySearch LaboratoriesSep 12, 2023 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to
RaySearch recalls software versions 5A, 5B, 6A including service packs due to potential failure to show allergy warnings for medication substances. Affected users should contact RaySearch for details.
RaySearchJul 17, 2023 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls 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,
Raysearch recalls Raystation radiation therapy software versions 9.0.0-13.1.0 with incorrect collimator angle in exported DICOM plans. Users may need to update software to prevent treatment errors.
RaysearchFeb 17, 2023 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation 11B
RaySearch Laboratories recalls RayStation 11B software versions 12.0.0.932, 12.1.0.1221, 12.0.3.68 due to potential misleading Linear Energy Transfer (LET) displays in dose evaluations and beam-specific distributions.
RaySearch LaboratoriesJun 10, 2022 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation 9B SP1. For radiation treatment planning.
RaySearch Laboratories recalls RayStation 9: Information may not propagate from RayTreat to RayCare during some workflows. Affected units: 9B SP1 software version 9.2.0.483. No remedy specified in recall notice.
RaySearch LaboratoriesJun 1, 2022 - UnratedMedical device
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 ,
RaySearch recalls specific versions of RayStation/RayPlan software due to display errors when new images are selected during cine loops. Affected versions include 6.0.0.24 through 9.2.0.483. No remedy is stated in the recall notice.
RaySearchDec 30, 2021 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14,
RaySearch recalls software versions 4-11A with specific build numbers due to potential under/overestimation of radiation density in treatment planning. Affected users should check their version and contact RaySearch for updates.
RaySearchSep 22, 2021 - Use cautionMedical device
RAYSEARCH LABORATORIES AB recalls TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7,
RaySearch Laboratories recalls RayStation software versions 6 through 11A with specific build numbers due to potential unexpected jaw position changes during radiation treatment planning if dose grid or target ROI is modified after optimization.
RaySearch LaboratoriesSep 9, 2021 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination
RaySearch Laboratories recalls RayStation versions 9A-11A with incorrect beam delivery positions. Affected software versions may cause treatment errors if used without correction.
RaySearch LaboratoriesJun 8, 2021 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls 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 ,
RaySearch Laboratories recalls RayStation treatment planning software versions 6.0.0.24 to 10.1.0.613 due to potential misleading dose evaluations after clinical goal edits. Affected users should contact support for updates.
RaySearch LaboratoriesApr 21, 2021 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B
RaySearch Laboratories recalls RayStation software versions 8.0.0.6 to 10.1.0.613 for potential incorrect total dose displays during radiation therapy treatment planning. Users should verify dose tracking settings to avoid treatment errors.
RaySearch LaboratoriesApr 7, 2021 - UnratedMedical device
RAYSEARCH LABORATORIES AB recalls 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
RaySearch Laboratories recalls RayStation software versions 9A-10B due to potential patient data not updating after check-in. Affected users should contact the company for updates.
RaySearch LaboratoriesMar 25, 2021 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare
RaySearch Laboratories recalls RayCare 3B software version 3.1.0.60341 for potential patient data loss when upgrading from older versions. Affected healthcare systems should check their software version.
RaySearch LaboratoriesMar 3, 2021 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of
RaySearch recalls specific versions of RayStation and RayPlan software due to potential dose labeling errors when merging clinical beams. Affected versions include 4.5 to 10.1 with certain service packs. No immediate action is required but users should check their software version.
RaySearchFeb 22, 2021 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs.
RaySearch recalls specific versions of RayStation and RayPlan software due to potential incorrect treatment plan reports, which could affect radiation therapy accuracy. Affected users should check their software versions.
RaySearchNov 11, 2020 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls 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,
RaySearch recalls specific software versions for radiation therapy planning due to potential incorrect reference links in imported treatment plans. Affected users should check version numbers and contact RaySearch for guidance.
RaySearchOct 8, 2020 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical
RaySearch Laboratories recalls RayCare software versions 2.2.2.30782, 2.2.3.53423, 3.0.1.43597, 3.1.0.60341, and 4.0.0.60621 for potential offline image review errors during use.
RaySearch LaboratoriesJul 29, 2020 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs)
RaySearch Laboratories recalls RayStation software versions 8A-9B due to potential treatment data import errors in radiation therapy systems. Affected users should check their software version and contact support for updates.
RaySearch LaboratoriesMay 26, 2020 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can
RaySearch Laboratories recalls RayStation 6 Service Pack 2 (UDI #07350002010075) due to potential underestimation of radiation dose in cancer treatment calculations.
RaySearch LaboratoriesMay 18, 2020 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1,
RaySearch Laboratories recalls RayStation software versions 4.0-9.1 due to potential inaccuracies in radiation treatment planning that could lead to uneven dose distribution in complex treatments.
RaySearchMar 4, 2020 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
RaySearch Laboratories recalls software version 8.1.2.5 for potential incorrect treatment planning calculations. Users should contact the company for updates.
RaySearch LaboratoriesFeb 20, 2020 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3,
RaySearch recalls software versions 4.0-9.0 for possible incorrect radiation dose calculations during cancer treatment planning. Users should verify their version and contact RaySearch for guidance.
RaySearchDec 19, 2019 - Use cautionMedical device
RAYSEARCH LABORATORIES AB recalls RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3,
RaySearch recalls specific versions of RayStation treatment planning software due to a bug that may set beam dose to default values, requiring recalibration before treatment approval.
RaySearchNov 18, 2019 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation
RaySearch Laboratories recalls specific RayStation software versions due to incorrect isocenter shifts in dose tracking calculations, which could affect radiation therapy accuracy.
RaySearch LaboratoriesNov 12, 2018 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning
RaySearch Laboratories recalls RayStation software versions 4.5 to 7 due to unsupported robust optimization for treatment plans. Affected users should contact for updates.
RaySearch LaboratoriesSep 21, 2018 - Use cautionMedical device
RAYSEARCH LABORATORIES AB recalls RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1),
RaySearch recalls specific versions of RayStation software for radiation therapy planning due to potential overdose risk if beam models are asymmetric. Users must verify their version and contact RaySearch for updates.
RaySearchJun 29, 2018 - Use cautionMedical device
RAYSEARCH LABORATORIES AB recalls RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1,
RaySearch recalls specific versions of RayStation radiation therapy software due to potential incorrect dose calculations in large or off-axis radiation fields, requiring validation with Beam 3D Modeling.
RaySearchJun 6, 2018 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a
RaySearch Laboratories recalls RayStation versions 6.0-7.0 due to potential dose calculation errors in radiation therapy planning. Users must verify calculations to avoid incorrect treatments.
RaySearch LaboratoriesMar 28, 2018 - Use cautionMedical device
RAYSEARCH LABORATORIES AB recalls Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11,
RaySearch Laboratories recalls RayStation 4.9-7 software versions with incorrect treatment volume delivery risk. Affected units may require software update to prevent patient safety issues.
RaySearch LaboratoriesJan 26, 2018 - Lower riskMedical device
RAYSEARCH LABORATORIES AB recalls RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9)
RaySearch Laboratories recalls specific RayStation software versions due to potential dose calculation errors in radiation therapy planning. Affected versions include 3.5 through 6.2.
RaySearch LaboratoriesNov 20, 2017 - Use cautionMedical device
RAYSEARCH LABORATORIES AB recalls RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The
RaySearch Laboratories recalls RayStation 6 software versions 6.0.0.24, 6.1.0.26, 6.1.1.2, and 6.2.0.7 due to potential incorrect radiation dose calculations during proton therapy QA checks.
RaySearch LaboratoriesJul 17, 2017
RAYSEARCH LABORATORIES AB recall questions
How many recalls has RAYSEARCH LABORATORIES AB had?
95 recalls from RAYSEARCH LABORATORIES AB are on record with U.S. safety agencies, from 2017–2026.
What is the most recent RAYSEARCH LABORATORIES AB recall?
RAYSEARCH LABORATORIES AB recalls RayCare 2024A SP1. Oncology Information Systems., dated May 20, 2026. Every RAYSEARCH LABORATORIES AB recall is listed on this page, newest first.
Why are RAYSEARCH LABORATORIES AB products recalled?
The most common reasons on record: Potential for reported SSD to be too high. (12).
What should I do if I have a recalled RAYSEARCH LABORATORIES AB product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new RAYSEARCH LABORATORIES AB recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.