Lower riskMedical device recall · FDA · Published September 17, 2025
ELEKTA MOSAIQ Oncology Software Builds 3.1.3-3.2.3.0 May Cause Medication Schedule
ELEKTA recalls specific MOSAIQ oncology software versions where appending care plans with medication orders may not match intended schedules. Affected users should check software versions and UDI codes.
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
Take action
Contact the company
📍Recalling firmELEKTA SOLUTIONS ABBox 7593, Haga Plan 4 · Stockholm, Sweden
“ELEKTA MOSAIQ Oncology Software Builds 3.1.3-3.2.3.0 May Cause Medication Schedule.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51280-elekta-mosaiq-oncology-software-builds-3-1-3-3-2. Based on FDA recall #Z-0503-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0503-2026%22&limit=1).
The FDA announced on Sept. 17, 2025, that ELEKTA SOLUTIONS AB is recalling MOSAIQ Oncology Information System software builds 3.1.3, 3.2.1, 3.2.2 and 3.2.3.0 due to a hazard where appended wave medication orders may not match the intended schedule.
How to tell if you have it
ELEKTA MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0
UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 through 3.1.3.4 (01)07340201500026(10)3.1.3.4
UDI Codes: 3.2.1.0 (01)07340201500071(10)3.2.1.0 through 3.2.3.0 (01)07340201500071(10)3.2.3.0
UPC: 07340201500026
UPC: 07340201500071
The hazard
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
Context
GovInfoNow's records show ELEKTA SOLUTIONS AB has 1 other recall on record since Sept. 28, 2021. Other recent recalls of similar products include Elekta MOSAIQ Oncology System Software Recall: Treatment Plan Loading Risk (May 21, 2026), Elekta MOSAIQ Oncology System Recall: Risk of Overtreatment in Particle Therapy (Dec. 10, 2025) and Medtronic SynchroMed Flex Infusion Software Issue: Steps May Not Program Correctly (April 8, 2026).
How to tell if you have this one
Check if your MOSAIQ software version is 3.1.3, 3.2.1, 3.2.2, or 3.2.3.0. Look for UDI codes starting with 3.1.3.0 (01)07340201500026(10) or 3.2.1.0 (01)07340201500071(10).
Brand
ELEKTA
Product
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Review your MOSAIQ software version to see if it is 3.1.3, 3.2.1, 3.2.2, or 3.2.3.0.
Verify UDI Codes
Confirm your UDI codes match the listed codes for affected versions (e.g., 3.1.3.0 (01)07340201500026(10)).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - U.S. Nationwide distribution in the state of NM and the countries of Canada, Malta, and South Africa.” 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 published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0503-2026 (September 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0503-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.