Lower riskMedical device recall · FDA · Published December 10, 2025
Elekta MOSAIQ Oncology System Recall: Risk of Overtreatment in Particle Therapy
Elekta recalls specific versions of MOSAIQ Oncology Information System with Particle Therapy License due to potential for repeated partial treatments causing overtreatment. Affected software versions include 3.10.200 to 3.2.3.1.
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
Take action
Contact the company
📍Recalling firmElekta, Inc.400 Perimeter Center Ter NE Ste 50 · Atlanta, GA 30346-1227
“Elekta MOSAIQ Oncology System Recall: Risk of Overtreatment in Particle Therapy.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50495-elekta-mosaiq-oncology-system-recall-risk-of-overtreatment-in-particle. Based on FDA recall #Z-1078-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1078-2026%22&limit=1).
The FDA announced on Dec. 10, 2025, that Elekta, Inc. is voluntarily recalling the MOSAIQ Oncology Information System with Particle Therapy License due to a risk of patient overtreatment. The agency issued recall number Z-1078-2026 for the device.
How to tell if you have it
Brand: Elekta
Product: MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Software Versions: 3.10.200, 3.1.1.0 up to and including v 3.2.3.1 with Particle Base
Distribution: US Nationwide distribution in the state of TX
The hazard
According to the FDA, using the system may result in overtreatment if a plan is delivered with the Particle Therapy IHE-RO TDW-II interface under specific conditions involving partial treatments or field interruptions. The hazard arises when the treatment unit does not check the meterset value, causing a partial treatment to be delivered twice.
Context
GovInfoNow's records show Elekta, Inc. has issued 39 other recalls since June 19, 2017. Recent similar recalls include the Elekta MOSAIQ Oncology System Software Recall (May 21, 2026), the Elekta Geneva Brachytherapy Applicator Recall (April 3, 2026), and the Elekta Leksell Vantage Arc System Recall (March 19, 2026). Other recent recalls of similar products include the RayStation/RayPlan Software 11A Recalls (Nov. 28, 2025), the IBA Proton Therapy System PROTEUS 235 Recall (Feb. 3, 2026), and the Fresenius Kabi Ivenix Infusion System Software Recall (Nov. 14, 2025).
How to tell if you have this one
Check if your MOSAIQ system has software versions 3.10.200 through 3.2.3.1 with Particle Base. The unique device identifiers (UDI-DI) 07340201500026 and 07340201500071 are also associated with this recall.
Brand
Elekta
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify your MOSAIQ software version by checking the system settings or documentation.
Contact Elekta
Reach out to Elekta directly for guidance on whether your system is affected and next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 42 days 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 recall addresses a potential for repeated partial treatments, but the risk is low and depends on specific workflow conditions. Elekta has not stated that this causes serious injury in normal use.
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-1078-2026 (December 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1078-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.