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Lower risk Medical device recall · FDA · Published May 21, 2026

Elekta MOSAIQ Oncology System Software Recall: Treatment Plan Loading Risk

Elekta recalls MOSAIQ Oncology Information System software version 3.2 due to potential failure to load adapted baseline shift plans during treatment, risking incorrect radiation therapy delivery.

🇺🇸 FDA recall #Z-2406-2026Medical deviceElekta ›
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Recalling firmElekta, Inc.400 Perimeter Center Ter NE Ste 50 · Atlanta, GA 30346-1227
✎ GovInfoNow plain-language explainer

What happened, in plain English

Elek: The Elekta MOSAIQ Oncology Information System software version 3.2 has been recalled because it may fail to load adapted baseline shift plans during radiation treatment when communication errors occur. This could lead to incorrect treatment delivery if the system does not properly handle these plans. Read more at govinfonow.com/recall/49098-elekta-mosaiq-oncology-system-software-recall-treatment-plan-loading-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/49098-elekta-mosaiq-oncology-system-software-recall-treatment-plan-loading-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2406-2026

Cite this page

“Elekta MOSAIQ Oncology System Software Recall: Treatment Plan Loading Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49098-elekta-mosaiq-oncology-system-software-recall-treatment-plan-loading-risk. Based on FDA recall #Z-2406-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2406-2026%22&limit=1).

Why it’s dangerous

The software may fail to load adapted baseline shift plans during treatment delivery when communication errors occur. This could result in incorrect radiation therapy delivery if the system does not properly handle these plans. The risk is specific to the software version and communication errors.

Who’s affected

Healthcare providers using the MOSAIQ Oncology Information System software version 3.2 for radiation treatment planning are most at risk. Patients receiving radiation therapy through this system could be affected if the software fails to load critical treatment plans.

How to tell if you have this one

Check for the software version 'MOSAIQ 3.2' on the system. The recall applies to the MOSAIQ Oncology Information System with UDI: 07340201500071.

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

What to do — step by step

  1. Check Software Version

    Verify the software version is MOSAIQ 3.2 by checking the system's version information.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 9 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY, NJ, KS, FL, IA, NM, TX and the countries of Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lithuania, Malta,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Iowa, Kansas, Louisiana, New Jersey, New Mexico, New York, Texas, Wisconsin.

Recall timeline

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

1. Firm started the recall: May 21, 202612. FDA classified it Class II: Jun 11, 202623. Published in FDA’s Enforcement Report: Jun 17, 202632026
  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-2406-2026 (May 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2406-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 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