Lower risk Medical device recall · FDA · Published November 12, 2018

RayStation software versions 3.5-8.0 have isocenter shift error in dose tracking

RaySearch Laboratories recalls specific RayStation software versions due to incorrect isocenter shifts in dose tracking calculations, which could affect radiation therapy accuracy.

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

🇺🇸 FDA recall #Z-0679-2019Medical device RaySearch Laboratories ›

Lower-risk recall

Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.

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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 software (3.5 through 8.0) because dose tracking calculations can shift the treatment target incorrectly. This could lead to inaccurate radiation therapy delivery if the software is used without the fix. Read more at govinfonow.com/recall/69482-raystation-software-versions-3-5-8-0-have-isocenter-shift.

Source Summary by GovInfoNow · govinfonow.com/recall/69482-raystation-software-versions-3-5-8-0-have-isocenter-shift · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0679-2019

Cite this page

“RayStation software versions 3.5-8.0 have isocenter shift error in dose tracking.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69482-raystation-software-versions-3-5-8-0-have-isocenter-shift. Based on FDA recall #Z-0679-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0679-2019%22&limit=1).

The FDA announced on 2018-11-12 that RaySearch Laboratories AB is recalling RayStation software versions 3.5 through 8A due to isocenter shifts in dose tracking. The agency stated the hazard involves incorrect interpretation of coordinate systems.

How to tell if you have it

RayStation 3.5, 4.0, 4.5, 4.7, 5, 6, 7 and 8A
Software versions: 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 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, 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, 8.0.0.61 or 8.0.1.10
Sold in AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NY, OH, OR, PA, RI, TN, TX, VA, VT, WA, WI
69 units affected

The hazard

Isocenter shifts occur when using dose tracking in the recalled RayStation versions. According to the FDA, these shifts are incorrectly interpreted according to the DICOM patient coordinate system.

Context

GovInfoNow's records show RaySearch Laboratories AB has 36 other recalls on record since 2017-07-17. Other recent recalls of similar products include RayCare 2:024A SP1 Oncology Software Data Loss Risk (2026-05-20), RayStation 2024B Software Recall: Radiation Dose Calculation Errors (2025-11-28), and RayStation 10B Software Version 10.1.0.613: DICOM UID Not Unique Risk (2025-08-08). Other recent recalls of similar products include Reflexion X1 Radiotherapy System Software Defect May Cause Incorrect Dose Delivery (2026-02-09), Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall (2026-06-19), and Hitachi Proton Beam Therapy Systems: Positioning Software Anomaly Risk (2026-02-06).

How to tell if you have this one

Check if your RayStation software version matches the listed numbers: 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 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, 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, 8.0.0.61, or 8.0.1.10.

Brand
RaySearch Laboratories
Category
Medical device

Based on the official FDA remedy

What to do — step by step

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 in 30 states.

FDA distribution: “AZ CA CO CT DE FL GA HI ID IL LA MA MD ME MI MO MS NC NJ NY OH OR PA RI TN TX VA VT WA WI” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Nov 12, 2018Firm started the recall
Dec 22, 2018FDA classified it Class II
Jan 2, 2019Published in FDA’s Enforcement Report
Apr 17, 2020FDA 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/69482-raystation-software-versions-3-5-8-0-have-isocenter-shift">RayStation software versions 3.5-8.0 have isocenter shift error in dose tracking (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-0679-2019 (November 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0679-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.