Elekta recalls specific software versions for Unity system due to potential contour data mismatch in motion monitoring workflows, which could affect treatment accuracy.
In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.
Elekta is recalling specific software versions for their Unity system. This recall is due to a possible mismatch between contour data and motion monitoring images during certain treatments, which could lead to inaccurate radiation therapy delivery.
In certain motion monitoring workflows, the software may display contour data that doesn't align with the actual motion monitoring images. This mismatch could cause radiation therapy to be delivered to the wrong area of the body, potentially reducing treatment effectiveness.
Patients receiving radiation therapy using Elekta Unity systems with the recalled software versions are affected. Medical professionals using these systems for treatment planning are most at risk of delivering inaccurate radiation doses.
Check if your Elekta Unity system has software versions R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, or R6.1.571. The recall applies to specific anatomy protocols like abdomen, head/neck, pelvis, and thorax treatments.
Identify your Elekta Unity software version by checking the system settings or documentation.
Reach out to your healthcare provider or Elekta for guidance on updating the software to a safe version.
No, the recall does not require immediate discontinuation. The software can be updated to a safe version without stopping treatment.
The affected software versions are R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, and R6.1.571.
Contact your healthcare provider or Elekta directly for instructions on updating to a safe software version.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-2297-2020 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-2297-2020 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.
