Elekta MOSAIQ Oncology System Drug Strength Recall: Order Changes May Revert
Elekta recalls MOSAIQ Oncology Information System software version 2.83 where drug strength settings may revert to original after ordering changes. Affected units run with First Data Bank (FDB) and have specific UDI/GTIN numbers.
Lower-risk recall
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
Contact the company
What happened, in plain English
Elekta is recalling a version of their MOSAIQ Oncology Information System software where drug strength settings can change during ordering but revert to original values. This could lead to incorrect drug dosing if the system reverts after a change. Read more at govinfonow.com/recall/61840-elekta-mosaiq-oncology-system-drug-strength-recall-order-changes-may.
Source Summary by GovInfoNow · govinfonow.com/recall/61840-elekta-mosaiq-oncology-system-drug-strength-recall-order-changes-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2591-2021
Cite this page
“Elekta MOSAIQ Oncology System Drug Strength Recall: Order Changes May Revert.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61840-elekta-mosaiq-oncology-system-drug-strength-recall-order-changes-may. Based on FDA recall #Z-2591-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2591-2021%22&limit=1).
Why it’s dangerous
The system allows changing drug strength during ordering but the saved setting reverts to the original value after the change. This means that if a healthcare provider adjusts the drug strength for a patient, the system might reset to the original value, potentially causing incorrect dosing.
Who’s affected
Healthcare providers using Elekta's MOSAIQ software with version 2.83 that runs with First Data Bank (FDB) are most at risk. Patients receiving treatment through this system could potentially receive incorrect drug dosing.
How to tell if you have this one
Check if your MOSAIQ software version is 2.83 and runs with First Data Bank (FDB). Affected units have UDI/GTIN number 0858164002367.
- Brand
Elekta- Category
Medical device
What to do — step by step
Check Software Version
Verify your MOSAIQ software version is 2.83 and runs with First Data Bank (FDB).
Where it went and when
Where it was distributed
Distributed in 17 states, and outside the U.S.
FDA distribution: “Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Idaho, Louisiana, Mississippi, Missouri, Nevada, New Hampshire, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Washington.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-2591-2021 (September 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2591-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.