RayStation software recall: Incorrect dose calculation risk
RaySearch America recalls RayStation 4-11B and RayPlan 1-8A software versions due to potential dose errors in radiation treatment planning. Affected users should contact RaySearch for details.
Lower-risk recall
Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.
Contact the company
What happened, in plain English
RaySearch America is recalling specific versions of its RayStation and RayPlan software used in radiation treatment planning. The software may calculate incorrect radiation doses to patients, which could lead to improper treatment. Read more at govinfonow.com/recall/61158-raystation-software-recall-incorrect-dose-calculation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61158-raystation-software-recall-incorrect-dose-calculation-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0850-2022
Cite this page
“RayStation software recall: Incorrect dose calculation risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61158-raystation-software-recall-incorrect-dose-calculation-risk. Based on FDA recall #Z-0850-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0850-2022%22&limit=1).
Why it’s dangerous
The software may miscalculate the distance between the radiation source and the patient's skin or surface, leading to incorrect radiation doses. This could result in under- or over-treatment of patients during radiation therapy.
Who’s affected
Medical professionals using RaySearch software for radiation treatment planning. Patients receiving treatment with affected software versions are at risk of incorrect radiation dosing.
How to tell if you have this one
Check if your software version is listed in the recall details: RayStation 4.0 (4.0.0.14) to RayStation 5, or RayPlan 1, 2, 7-11B with specific service packs. Also check the UDI numbers provided in the recall.
- Brand
RaySearch- Category
Medical device
What to do — step by step
Contact RaySearch
Reach out to RaySearch America for specific instructions on how to verify your software version and receive a remedy.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 43 states.
FDA distribution: “US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
How can I check if my software is affected?
Check your software version against the list of affected versions provided in the recall notice, or verify your Unique Device Identifier (UDI) number.
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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-0850-2022 (February 11, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0850-2022 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.