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
Elekta is recalling certain versions of its MOSAIQ Oncology Information System with Particle Therapy License. This software may cause repeated partial treatments if specific workflow conditions are met, leading to potential overtreatment of patients.
The software may deliver partial treatments twice if the system does not check metered values after a partial treatment. This happens when specific workflow conditions are met, such as manual recording of partial treatments followed by treatment interruptions.
Healthcare providers using the recalled software versions are affected. Patients receiving treatments through this system may be at risk of receiving extra radiation doses if the software error occurs.
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.
Identify your MOSAIQ software version by checking the system settings or documentation.
Reach out to Elekta directly for guidance on whether your system is affected and next steps.
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.
Software versions from 3.10.200 to 3.2.3.1 with Particle Base are affected, including specific updates like 3.1.1.0 through 3.2.3.1.
Check your software version and unique device identifiers (UDI-DI) 07340201500026 or 07340201500071 to confirm if your system is part of this recall.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1078-2026 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1078-2026 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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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.