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Use caution Medical device recall · FDA · Published December 13, 2018

Elekta MOSAIQ Oncology System Recall: Risk of Overdose Without Wedge

Elekta recalls MOSAIQ Oncology Information System and Sequencer versions 1.0+ and 6.1+ due to potential overdose from missing wedge IDs in radiation treatment plans.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0821-2019Medical deviceElekta ›
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Contact the company

Recalling firmElekta, Inc.400 Perimeter Center Ter NE Ste 50 · Atlanta, GA 30346-1227
✎ GovInfoNow plain-language explainer

Elekta is recalling its MOSAIQ Oncology Information System and Sequencer software because missing wedge IDs in radiation treatment plans could cause patients to receive more radiation than intended. This risk affects radiation oncology facilities using the system for cancer treatment planning. Read more at govinfonow.com/recall/69340-elekta-mosaiq-oncology-system-recall-risk-of-overdose-without-wedge.

Source Summary by GovInfoNow · govinfonow.com/recall/69340-elekta-mosaiq-oncology-system-recall-risk-of-overdose-without-wedge · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0821-2019

Cite this page

“Elekta MOSAIQ Oncology System Recall: Risk of Overdose Without Wedge.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69340-elekta-mosaiq-oncology-system-recall-risk-of-overdose-without-wedge. Based on FDA recall #Z-0821-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0821-2019%22&limit=1).

The FDA announced on 2018-12-13 that Elekta, Inc. is recalling its MOSAIQ Oncology Information System and Sequencer because Wedge IDs may be omitted from DICOM RT PLAN files, causing incorrect radiation doses. GovInfoNow's records show the recall involves 3,950 units total.

How to tell if you have it

  • Brand: Elekta
  • Product: MOSAIQ Oncology Information System and Sequencer
  • Versions: MOSAIQ Radiation Oncology version 1.0 and higher; Multi-ACCESS version 6.1 and higher
  • UDIs: 858164002084, 858164002091, 858164002107, 858164002220, 858164002237
  • Quantity: 3,950 units total (1,747 US)
  • Distribution: U.S. Nationwide including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, and Puerto Rico

The hazard

According to the FDA, Wedge IDs may not be included in the DICOM RT PLAN sent from the Treatment Planning System (TPS). This omission causes the field in MOSAIQ to be created without a wedge, resulting in the treatment receiving more dose than indicated in the plan.

Context

GovInfoNow's records show Elekta, Inc. has 39 other recalls on record since 2017-06-19. Other recent recalls of similar products include Elekta MOSAIQ Oncology System Software Recall (2026-05-21), Elekta Advanced Gynecological Applicator Recall (2026-04-03), and Elekta Leksell Vantage Arc System Recall (2026-03-19). Other recent recalls of similar products include RayStation/RayStation Software 11A Recalls (2025-11-28), RayStation/RayPlan 10B Software Recall (2025-11-28), and RayStation/RayPlan Software Recall (2025-11-28).

How to tell if you have this one

Check for MOSAIQ Radiation Oncology version 1.0 or higher and Multi-ACCESS version 6.1 or higher. The unique device identifiers (UDIs) listed in the recall include 858164002084, 858164002091, 858164002107, 858164002220, and 858164002237.

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

What to do — step by step

  1. Check System Version

    Verify your MOSAIQ Radiation Oncology version is 1.0 or higher and Multi-ACCESS version is 6.1 or higher.

  2. Review Device Identifiers

    Confirm your system's unique device identifiers (UDIs) match those listed in the recall: 858164002084, 858164002091, 858164002107, 858164002220, or 858164002237.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “U.S. Nationwide distribution to the following states AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,…” 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, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

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

1. Firm started the recall: Dec 13, 201812. FDA classified it Class II: Feb 8, 201923. Published in FDA’s Enforcement Report: Feb 20, 2019320182019
  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-0821-2019 (December 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0821-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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