Unrated Medical device recall · FDA · Published December 4, 2018

Elekta MOSAIQ Version 2.64: Incorrect Isocenter Risk in Treatment Planning

Elekta recalls MOSAIQ Oncology Information System Version 2.64 due to potential incorrect isocenter settings when copying treatment fields, which could affect radiation therapy accuracy.

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

🇺🇸 FDA recall #Z-0686-2019Medical device Elekta ›

Recall notice

If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.

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Contact the company

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

✎ GovInfoNow plain-language explainer

Elekta is recalling its MOSAIQ Oncology Information System version 2.64 because copying treatment fields can create incorrect isocenter settings. This may lead to inaccurate radiation therapy delivery if the system is used without proper verification. Read more at govinfonow.com/recall/69388-elekta-mosaiq-version-2-64-incorrect-isocenter-risk-in-treatment.

Source Summary by GovInfoNow · govinfonow.com/recall/69388-elekta-mosaiq-version-2-64-incorrect-isocenter-risk-in-treatment · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0686-2019

Cite this page

“Elekta MOSAIQ Version 2.64: Incorrect Isocenter Risk in Treatment Planning.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69388-elekta-mosaiq-version-2-64-incorrect-isocenter-risk-in-treatment. Based on FDA recall #Z-0686-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0686-2019%22&limit=1).

The FDA announced on 2018-12-04 that Elekta, Inc. voluntarily recalled its MOSAIQ Oncology Information System Version 2.64 due to a software hazard affecting treatment workflows. The recall involves 551 units distributed globally.

How to tell if you have it

Brand: Elekta
Product: MOSAIQ Oncology Information System Version 2.64
Software Build: 2.64 SP9 and higher
UPC: 00858164002091

The hazard

According to the FDA, if a Setup field is created by copying a treatment field or another setup field, the copied field will have the same isocenter as the parent. This isocenter may not be correct for imaging when sent to the machine.

Context

GovInfoNow's records show Elekta, Inc. has 39 other recalls on record since 2017-06-19. Other recent recalls of similar products include Elekta MOSAIQ Oncology System Software Recall (2026-05-21), Elekta Fletcher CT/MR Shielded Applicator Set Recall (2026-04-03), and Elekta Leksell Vantage Arc System Recall (2026-03-19). Other recent recalls of similar products include RayStation/RayPlan 10B Software Recall (2025-11-28), Hitachi Proton Beam Therapy System Recall (2026-02-06), and RayStation/RayPlan Software 11A Recalls (2025-11-28).

How to tell if you have this one

The MOSAIQ Oncology Information System version 2.64 (software build 2.64 SP9 or higher) used in radiation treatment planning. The recall applies to systems with the UDI (01)00858164002091(10)2.64.235.

Brand
Elekta
Product
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your MOSAIQ system version by checking the software build number in the system settings.

How this recall unfolded

Recall timeline

FDA terminated this recall 7.2 years after the firm started it.

Dec 4, 2018Firm started the recall
Dec 27, 2018FDA classified it Class II
Jan 2, 2019Published in FDA’s Enforcement Report
Feb 23, 2026FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/69388-elekta-mosaiq-version-2-64-incorrect-isocenter-risk-in-treatment">Elekta MOSAIQ Version 2.64: Incorrect Isocenter Risk in Treatment Planning (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-0686-2019 (December 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0686-2019 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.