Lower riskMedical device recall · FDA · Published June 24, 2019
Elekta Unity Radiation Therapy System Recall: Missing QA Software Values
Elekta recalls Unity radiation therapy systems due to QA software not displaying MR to MV offset values, risking treatment errors. Affected units include specific model numbers and installation dates.
The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.
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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 Unity radiation therapy systems because the quality assurance software fails to show stored magnetic resonance to megavoltage offset values. This means users cannot independently check these critical alignment values during quality assurance checks, potentially leading to treatment errors. Read more at govinfonow.com/recall/67615-elekta-unity-radiation-therapy-system-recall-missing-qa-software-values.
“Elekta Unity Radiation Therapy System Recall: Missing QA Software Values.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67615-elekta-unity-radiation-therapy-system-recall-missing-qa-software-values. Based on FDA recall #Z-1980-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1980-2019%22&limit=1).
The FDA announced on June 24, 2019, that Elekta, Inc. is recalling its Elekta Unity Image-Guided Radiation Therapy Systems because the QA software fails to display stored MR to MV offset values. The recall affects 12 units distributed in Texas, Wisconsin, Canada, Denmark, Germany, Italy, the Netherlands, Sweden, and the UK.
How to tell if you have it
Brand: Elekta
Product: Elekta Unity, Image-Guided Radiation Therapy System
Units affected: 12
Distribution: TX, WI, Canada, Denmark, Germany, Italy, Netherlands, Sweden, UK
The hazard
The QA software solution to perform the MR to MV alignment check does not display the stored MR to MV offset values. This prevents users from independently inspecting the values during their quality assurance process.
Context
GovInfoNow's records show Elekta, Inc. has had 39 other recalls since June 19, 2017. Recent brand recalls include the May 21, 2026 MOSAIQ Oncology System Software Recall for treatment plan loading risks and the April 3, 2026 Geneva Brachytherapy Applicator Recall for IU tube detachment risks. Other recent recalls of similar products include the November 28, 2025 RayStation Software Version 12A Recalls for radiation dose calculation errors and the November 28, 2025 RayStation/RayPlan Software Recall for radiation dose calculation errors in some regions.
How to tell if you have this one
Check for the specific model numbers listed in the recall notice: UNITY SYSTEM/13553-006/600003, UNITY SYSTEM/10817-011/600010, and other installed product codes. These units were installed with specific serial numbers and dates.
Brand
Elekta
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Display
Verify if the QA software shows stored magnetic resonance to megavoltage offset values during quality assurance checks.
Where it went and when
Where it was distributed
Distributed in Texas and Wisconsin, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US Distribution to states of: TX & WI, and Internationally to: Canada, Denmark, Germany, Italy, Netherlands, Sweden, and the UK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas, Wisconsin.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall affects medical facilities using the system, not patients directly. Patients receive treatment as usual unless the facility follows the recall steps.
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-1980-2019 (June 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1980-2019 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.