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Lower risk Medical device recall · FDA · Published June 21, 2017

Elekta MOSAIQ Oncology System Recalls Outdated Information Risk

Elekta recalls MOSAIQ Oncology Information System versions 2.50.05+ due to outdated information retention in order sets, potentially affecting treatment planning accuracy.

🇺🇸 FDA recall #Z-2633-2017Medical 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

Elekta is recalling versions 2.50.05 and higher of its MOSAIQ Oncology Information System because updating order sets doesn't refresh associated care plans. This could lead to outdated treatment information being used, which might affect patient safety during radiation or chemotherapy procedures. Read more at govinfonow.com/recall/73778-elekta-mosaiq-oncology-system-recalls-outdated-information-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/73778-elekta-mosaiq-oncology-system-recalls-outdated-information-risk · Updated September 22, 2026 · FDA enforcement record: FDA #Z-2633-2017

Cite this page

“Elekta MOSAIQ Oncology System Recalls Outdated Information Risk.” GovInfoNow, updated September 22, 2026. https://govinfonow.com/recall/73778-elekta-mosaiq-oncology-system-recalls-outdated-information-risk. Based on FDA recall #Z-2633-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2633-2017%22&limit=1).

Why it’s dangerous

The system fails to update care plans when order sets are modified, meaning outdated information might remain in the system. This could lead to incorrect treatment planning if the system is used for radiation or chemotherapy procedures without current information.

Who’s affected

Healthcare providers using Elekta's MOSAIQ system for radiation or chemotherapy treatment planning are most at risk. Patients receiving care through this system could be affected if outdated information is used in treatment decisions.

How to tell if you have this one

Check if you have MOSAIQ Oncology Information System software versions 2.50.05 or higher. The system is used for managing treatment workflows in radiation and chemotherapy settings.

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

What to do — step by step

  1. Check Software Version

    Review your MOSAIQ software version to confirm if it is 2.50.05 or higher.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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: “Worldwide Distribution - US Nationwide and the countries of ANTIGUA AND BARBUDA, AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, CHEZ REPUBLIC, GERMANY, HUNGARY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, AND UK” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

1. Firm started the recall: Jun 21, 201712. FDA classified it Class II: Jun 27, 201723. Published in FDA’s Enforcement Report: Jul 5, 201734. FDA terminated the recall: Jul 11, 2018420172018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-2633-2017 (June 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2633-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on September 22, 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