Lower risk Medical device recall · FDA · Published August 3, 2018

Elekta MOSAIQ Oncology System Recall: Order Status Shows Approved After Completion

Elekta recalls MOSAIQ Oncology Information System software builds 2.64 SP3 and higher due to order status not updating correctly after completion. Affected users should contact support for updates.

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

🇺🇸 FDA recall #Z-2917-2018Medical device Elekta ›

Lower-risk recall

Order Status Remains Approved When Should Indicate Complete.

Take action

Contact the company

Recalling firmElekta, Inc.400 Perimeter Center Ter NE Ste 50 · Atlanta, GA 30346-1227

✎ GovInfoNow plain-language explainer

Elek: The MOSAIQ Oncology Information System software builds 2.64 SP3 and higher have been recalled because order status remains approved after completion. This could cause confusion in medical records and treatment planning. Read more at govinfonow.com/recall/70191-elekta-mosaiq-oncology-system-recall-order-status-shows-approved-after.

Source Summary by GovInfoNow · govinfonow.com/recall/70191-elekta-mosaiq-oncology-system-recall-order-status-shows-approved-after · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2917-2018

Cite this page

“Elekta MOSAIQ Oncology System Recall: Order Status Shows Approved After Completion.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70191-elekta-mosaiq-oncology-system-recall-order-status-shows-approved-after. Based on FDA recall #Z-2917-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2917-2018%22&limit=1).

The FDA announced on Aug. 3, 2018, that Elekta, Inc. voluntarily recalled its MOSAIQ Oncology Information System because order status remains approved when it should indicate complete. The agency classified the recall as Class II.

How to tell if you have it

Brand: Elekta
Product: MOSAIQ Oncology Information System
Software Build(s): 2.64 SP3 and higher

The hazard

The hazard is that the order status remains approved when it should indicate complete.

Context

GovInfoNow's records show Elekta, Inc. has 39 other recalls on record since June 19, 2017. Other recent recalls of similar products include Elekta MOSAIQ Oncology System Software Recall (May 21, 2026), Elekta Advanced Gynecological Applicator Recall (April 3, 2026), and Elekta Leksell Vantage Arc System Recall (March 19, 2026). Other recent recalls of similar products include Siemens SOMATOM X.ceed Software Applications Recall (Dec. 19, 2025) and Siemens CT Software Applications Recalled (Dec. 19, 2025).

How to tell if you have this one

Check if your MOSAIQ Oncology Information System uses software builds 2.64 SP3 or higher. The recall applies to systems sold with these specific software versions.

Brand
Elekta
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Support
Reach out to Elekta for guidance on updating the software or resolving the issue.

Where it went and when

Where it was distributed

Distributed in 39 states and D.C., and outside the U.S.

FDA distribution: “AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, WA, WI, WV, and WY Australia, Canada, Ireland, New Zealand, Portugal, Singapore, South Africa,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 6.1 years after the firm started it.

Aug 3, 2018Firm started the recall
Aug 23, 2018FDA classified it Class II
Aug 29, 2018Published in FDA’s Enforcement Report
Sep 23, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Elekta recalls

Link to this recall

<a href="https://govinfonow.com/recall/70191-elekta-mosaiq-oncology-system-recall-order-status-shows-approved-after">Elekta MOSAIQ Oncology System Recall: Order Status Shows Approved After Completion (GovInfoNow)</a>

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-2917-2018 (August 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2917-2018 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.