Elekta MOSAIQ Oncology Software May Have Incorrect Image Offsets for LINACs
Elekta recalls specific versions of its MOSAIQ Oncology Information System software due to potential incorrect image offsets for Linear Accelerators not characterized at IEC61217 scale.
Recall notice
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Contact the company
What happened, in plain English
Elekta is recalling specific software versions of its MOSAIQ Oncology Information System. The software may calculate incorrect image offsets for certain types of cancer radiation machines, which could affect treatment accuracy. Read more at govinfonow.com/recall/53083-elekta-mosaiq-oncology-software-may-have-incorrect-image-offsets-for.
Source Summary by GovInfoNow · govinfonow.com/recall/53083-elekta-mosaiq-oncology-software-may-have-incorrect-image-offsets-for · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1162-2025
Cite this page
“Elekta MOSAIQ Oncology Software May Have Incorrect Image Offsets for LINACs.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53083-elekta-mosaiq-oncology-software-may-have-incorrect-image-offsets-for. Based on FDA recall #Z-1162-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1162-2025%22&limit=1).
Why it’s dangerous
The software may calculate incorrect image offsets for Linear Accelerators (LINACs) that have not been characterized at the IEC61217 scale. This could lead to inaccurate radiation treatment planning, potentially affecting treatment outcomes for cancer patients.
Who’s affected
Users of Elekta's MOSAIQ Oncology Information System software versions listed in the recall are affected. Medical professionals using these software versions for cancer treatment planning are most at risk.
How to tell if you have this one
Check if you have Elekta's MOSAIQ Oncology Information System software versions listed in the recall, including 3.1.2.0 through 3.2.1.4 with specific UDI codes.
- Brand
Elekta- Product
MOSAIQ Oncology Information System- Category
Medical device
What to do — step by step
Check Software Version
Identify your software version by checking the UDI codes listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
FDA distribution: “US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina Brazil Canada France Germany Hong Kong Italy Japan Korea, Republic of Malta Netherlands Panama South Africa Spain Taiwan Thailand Turkey Venezuela” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Florida, Iowa, Pennsylvania, Utah.
Recall timeline
FDA published this recall 35 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-1162-2025 (January 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1162-2025 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.