Use caution Medical device recall · FDA · Published June 6, 2018

RayStation Radiation Therapy Software: Incorrect Dose Calculations in Large Fields

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2554-2018Medical device RaySearch ›

Use caution until it’s fixed

The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Modeling module in RayPhysics/RayPlan Physics. The user must be aware to avoid incorrect dose calculations during treatment planning.

Take action

Contact the company

Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden

✎ GovInfoNow plain-language explainer

RaySearch is recalling specific versions of its RayStation radiation therapy software because some users have experienced incorrect dose calculations in large or off-axis radiation fields. This could lead to improper treatment planning if not corrected using the Beam 3D Modeling module. Read more at govinfonow.com/recall/70899-raystation-radiation-therapy-software-incorrect-dose-calculations-in-large-fields.

Source Summary by GovInfoNow · govinfonow.com/recall/70899-raystation-radiation-therapy-software-incorrect-dose-calculations-in-large-fields · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2554-2018

Cite this page

“RayStation Radiation Therapy Software: Incorrect Dose Calculations in Large Fields.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70899-raystation-radiation-therapy-software-incorrect-dose-calculations-in-large-fields. Based on FDA recall #Z-2554-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2554-2018%22&limit=1).

The FDA announced on June 6, 2018, that RaySearch Laboratories AB is recalling the RayStation Radiation Therapy Treatment Planning System due to erroneous beam profile correction parameters. The agency stated the recall was voluntary and initiated by the firm.

How to tell if you have it

Brand: RaySearch
Product: RayStation Radiation Therapy Treatment Planning System
Model numbers: 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0
Version numbers: 2.5.1.89, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.3.0.14, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, 7.0.0.19
Units affected: 718

The hazard

Context

GovInfoNow's records show RaySearch Laboratories AB has 36 other recalls on record since July 17, 2017. Other recent recalls of similar products include RayCare 2:024A SP4 Oncology Software Data Loss Risk (May 20, 2026), RayStation Software Version 15.2.0/15.1.3 Radiation Dose Calculation Risk (Nov. 28, 2025), and RayStation Software Version 6.1.1.2-6.3.0.6 Recall (Aug. 8, 2025). Other recent recalls of similar products include Reflexion X1 Radiotherapy System Software Defect May Cause Incorrect Dose Delivery (Feb. 9, 2026), Hitachi Proton Beam Therapy Systems: Positioning Software Anomaly Risk (Feb. 6, 2026), and Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall (June 19, 2026).

How to tell if you have this one

Check if your RayStation software version is listed among 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, or 7.0. The software is used for radiation therapy treatment planning by trained medical professionals.

Brand
RaySearch
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Identify your RayStation version by checking the software's version number in the system settings.
Validate Dose Calculations
Use the Beam 3D Modeling module in RayPhysics/RayPlan Physics to verify dose calculations in large or off-axis fields.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

Jun 6, 2018Firm started the recall
Jul 26, 2018FDA classified it Class II
Aug 1, 2018Published in FDA’s Enforcement Report
Apr 4, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/70899-raystation-radiation-therapy-software-incorrect-dose-calculations-in-large-fields">RayStation Radiation Therapy Software: Incorrect Dose Calculations in Large Fields (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2554-2018 (June 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2554-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.