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.
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.
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.
When a treatment field is copied, the system may retain the same isocenter as the original field. If this incorrect isocenter is sent to the radiation machine, it could cause inaccurate radiation delivery during treatment.
Oncology clinics and hospitals using MOSAIQ version 2.64 for radiation treatment planning. Patients receiving radiation therapy at these facilities are at risk if the system is misconfigured.
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.
Verify your MOSAIQ system version by checking the software build number in the system settings.
The recall applies to systems used in radiation treatment planning. If you use MOSAIQ version 2.64, you should check for the issue before treatment.
Check your software build number; affected systems have build 2.64 SP9 or higher with UDI (01)00858164002091(10)2.64.235.
The recall does not specify a remedy, so contact Elekta directly for guidance on resolving the isocenter issue.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-0686-2019 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0686-2019 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.
