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Lower risk Medical device recall · FDA · Published March 4, 2020

RayStation Software Recalled: Risk of Inaccurate Radiation Treatment Planning

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.

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

🇺🇸 FDA recall #Z-1598-2020Medical deviceRaySearch ›
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Contact the company

Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling several versions of their RayStation radiation treatment planning software. Using these versions with certain Siemens linear accelerators may cause uneven radiation doses in treatment areas, potentially affecting treatment accuracy. Read more at govinfonow.com/recall/65720-raystation-software-recalled-risk-of-inaccurate-radiation-treatment-planning.

Source Summary by GovInfoNow · govinfonow.com/recall/65720-raystation-software-recalled-risk-of-inaccurate-radiation-treatment-planning · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1598-2020

Cite this page

“RayStation Software Recalled: Risk of Inaccurate Radiation Treatment Planning.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65720-raystation-software-recalled-risk-of-inaccurate-radiation-treatment-planning. Based on FDA recall #Z-1598-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1598-2020%22&limit=1).

The FDA announced on March 4, 2020, that RaySearch Laboratories AB is recalling RayStation standalone software treatment planning systems due to potential radiation dose errors. The agency stated the hazard involves restricted maximum field openings for Siemens Virtual Wedge fields.

How to tell if you have it

  • Brand: RaySearch
  • Product: 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
  • Units affected: 1389 licenses

The hazard

According to the FDA, the physical limitations of the treatment machine cause the maximum field opening for Siemens Virtual Wedge fields to be more restricted than recommended. Delivering a larger field opening with a virtual wedge results in a high dose plateau region at the toe side of the field beyond the recommended field size instead of a wedged field shape.

Context

GovInfoNow's records show RaySearch Laboratories AB has issued 36 other recalls since July 17, 2017. Recent similar recalls include the RayCare 2:024A SP4 Oncology Software Data Loss Risk (May 20, 2026), the RayStation 10B Software Radiation Dose Errors Recall (Nov. 28, 2025), and the RayStation Software Version 13.0.0.1547 Unique DICOM IDs Risk Recall (Aug. 8, 2025). Other recent recalls of similar products include the Hitachi Proton Beam Therapy System Positioning Software Anomaly Risk (Feb. 6, 2026) and the Elekta Leksell GammaPlan 11.1 Software Incorrect Patient Irradiation Recall (Dec. 12, 2025).

How to tell if you have this one

Check if you have RayStation software versions 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, or 9.1. The software is used for radiation therapy planning with Siemens linear accelerators.

  • Brand
    RaySearch
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Identify your RayStation software version by checking the version numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 36 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 28 days after the firm started it.

1. Firm started the recall: Mar 4, 202012. FDA classified it Class II: Mar 26, 202023. Published in FDA’s Enforcement Report: Apr 1, 202032020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this software?

No, the recall does not require immediate discontinuation of use. The software can continue to be used with proper configuration and monitoring.

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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-1598-2020 (March 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1598-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA