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Unrated Medical device recall · FDA · Published March 25, 2021

RayStation Software Version 9A-10B Recalls: Patient Data Not Updating Correctly

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.

🇺🇸 FDA recall #Z-1427-2021Medical deviceRaySearch Laboratories ›
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Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

What happened, in plain English

RaySearch Laboratories is recalling specific versions of their RayStation software (9A through 10B) because patient data might not update correctly after a patient is checked in. This could lead to incorrect treatment planning if the software doesn't reflect the latest patient information. Read more at govinfonow.com/recall/62940-raystation-software-version-9a-10b-recalls-patient-data-not-updating.

Source Summary by GovInfoNow · govinfonow.com/recall/62940-raystation-software-version-9a-10b-recalls-patient-data-not-updating · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1427-2021

Cite this page

“RayStation Software Version 9A-10B Recalls: Patient Data Not Updating Correctly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62940-raystation-software-version-9a-10b-recalls-patient-data-not-updating. Based on FDA recall #Z-1427-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1427-2021%22&limit=1).

Why it’s dangerous

The software may not update patient flags correctly after a patient is checked in. This could cause treatment plans to be based on outdated information, potentially leading to incorrect radiation doses or missed patient details.

Who’s affected

Healthcare professionals using RayStation software for radiation treatment planning are most likely affected. The risk is highest for those who rely on the software to track patient data accurately.

How to tell if you have this one

Check your RayStation software version numbers: 9A, 9B, 10A, or 10B. The affected versions include specific model numbers like (9A)9.0.0.113, 9B (9.1.0.933), and others listed in the recall notice.

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

What to do — step by step

  1. Check Software Version

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

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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

Distributed nationwide.

Recall timeline

FDA published this recall 27 days after the firm started it.

1. Firm started the recall: Mar 25, 202112. FDA classified it Class II: Apr 15, 202123. Published in FDA’s Enforcement Report: Apr 21, 202132021
  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.

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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-1427-2021 (March 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1427-2021 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