Elekta MOSAIQ Radiation Therapy System Recall: Incorrect Treatment Risk
Elek: Recalls all MOSAIQ Medical Charged-Particle Radiation Therapy System software builds due to risk of incorrect radiation targeting during treatment. No remedy specified.
Recall notice
The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.
Contact the company
What happened, in plain English
Elekta is recalling all versions of its MOSAIQ Medical Charged-Particle Radiation Therapy System software. This could cause radiation therapy to be directed to the wrong body area, potentially harming patients. Read more at govinfonow.com/recall/73493-elekta-mosaiq-radiation-therapy-system-recall-incorrect-treatment-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73493-elekta-mosaiq-radiation-therapy-system-recall-incorrect-treatment-risk · Updated September 21, 2026 · FDA enforcement record: FDA #Z-3110-2017
Cite this page
“Elekta MOSAIQ Radiation Therapy System Recall: Incorrect Treatment Risk.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73493-elekta-mosaiq-radiation-therapy-system-recall-incorrect-treatment-risk. Based on FDA recall #Z-3110-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3110-2017%22&limit=1).
Why it’s dangerous
The system's couch move assistant (CMA) can shift the treatment table vertically in the wrong direction. This misalignment may direct radiation to an incorrect body area during therapy, risking patient harm.
Who’s affected
Patients receiving radiation therapy using this system are affected. Medical professionals using the equipment are at risk if they do not address the issue.
How to tell if you have this one
The recalled product is Elekta's MOSAIQ Medical Charged-Particle Radiation Therapy System with all software builds. This system is used for radiation therapy treatments.
- Brand
Elekta- Category
Medical device
What to do — step by step
Check System Software
Verify if your MOSAIQ system uses the recalled software builds by checking the system's software version.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 47 states.
FDA distribution: “Worldwide distribution. US nationwide to AK, AL, AR, AZ, CA, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, District of…” 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, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, 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, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- 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-3110-2017 (June 30, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3110-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 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.