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Unrated Medical device recall · FDA · Published December 30, 2021

RaySearch RayStation/RayPlan Software Version 6.0.0.24 - Display Error Risk

RaySearch recalls specific versions of RayStation/RayPlan software due to display errors when new images are selected during cine loops. Affected versions include 6.0.0.24 through 9.2.0.483. No remedy is stated in the recall notice.

🇺🇸 FDA recall #Z-0732-2022Medical deviceRaySearch ›
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Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling specific versions of their RayStation and RayPlan radiation therapy software. The issue causes images to display incorrectly when new data is added during active cine loops, potentially leading to treatment planning errors. This affects medical professionals using these software versions. Read more at govinfonow.com/recall/61324-raysearch-raystation-rayplan-software-version-6-0-0-24-display.

Source Summary by GovInfoNow · govinfonow.com/recall/61324-raysearch-raystation-rayplan-software-version-6-0-0-24-display · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0732-2022

Cite this page

“RaySearch RayStation/RayPlan Software Version 6.0.0.24 - Display Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61324-raysearch-raystation-rayplan-software-version-6-0-0-24-display. Based on FDA recall #Z-0732-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0732-2022%22&limit=1).

The FDA announced on Dec. 30, 2021, that RaySearch Laboratories AB is recalling RayStation/RayPlan radiation therapy treatment planning software versions 6.0.0.24 through 9.2.0.483 due to a display error hazard. The agency issued recall number Z-0732-2022 for the voluntary Class II recall affecting 75 licenses distributed nationwide.

How to tell if you have it

  • Brand: RaySearch
  • Product: RayStation/RayPlan software
  • Versions: 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483
  • UDI codes: 07350002010013, 07350002010082, 07350002010075, 07350002010242, 07350002010068, 07350002010112, 07350002010136, 07350002010129, 07350002010204, 07350002010235, 07350002010174, 07350002010266, 07350002010297
  • Quantity: 75 Licenses

The hazard

According to the FDA, if a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This error also occurs for any new patient or case opened while the cine loop is running.

Context

GovInfoNow's records show RaySearch Laboratories AB has issued 36 other recalls since July 17, 2017. Recent brand recalls include a May 20, 2026 recall for RayCare 2:024A SP1 Oncology Software regarding data loss risk and a Nov. 28, 2025 recall for RayStation 2024B Software concerning radiation dose calculation errors. Other recent recalls of similar products include Elekta Leksell GammaPlan software recalls on Dec. 12, 2025, and a Philips IQon Spectral CT Software recall on Aug. 7, 2026.

How to tell if you have this one

Check if your software version is listed in the recall: 6.0.0.24 through 9.2.0.483. The UDI numbers are 07350002010013 through 07350002010297. This applies to RaySearch RayStation and RayPlan software used in radiation therapy treatment planning.

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

What to do — step by step

  1. Check Software Version

    Verify your RayStation or RayPlan software version against the list of affected versions provided 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 distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Dec 30, 202112. FDA classified it Class II: Mar 8, 202223. Published in FDA’s Enforcement Report: Mar 16, 2022320212022
  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

What versions of RayStation/RayPlan are affected?

Software versions 6.0.0.24 through 9.2.0.483, including specific service packs and build numbers listed in the recall notice.

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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-0732-2022 (December 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0732-2022 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.
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