Elekta MOSAIQ Oncology Software May Have Incorrect Image Offsets for LINACs

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

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✎ GovInfoNow plain-language explainer

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.

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
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Identify your software version by checking the UDI codes listed in the recall notice.

✎ GovInfoNow

Questions people ask

What software versions are affected?

Software versions 3.1.2.0 through 3.2.1.4 with specific UDI codes are affected.

Is there a fix for this issue?

The recall notice does not mention a fix or remedy for this issue.

How does this affect cancer treatment?

Incorrect image offsets could lead to inaccurate radiation treatment planning, potentially affecting treatment outcomes for cancer patients.

Take action

Contact Elekta

We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1162-2025 — Elekta Elekta

Hello,

I own a Elekta that is covered by recall Z-1162-2025 from Elekta.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Elekta, Inc. recalls MOSAIQ Oncology Information System

Recall notice