Elekta recalls Unity radiation therapy systems using MRI for potential image misalignment during respiratory motion. Users must select correct scan protocols to avoid treatment errors.
Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
Elekta is recalling its Unity radiation therapy systems that use MRI. The images may not show the correct anatomy position during breathing movements, which could lead to inaccurate treatment planning. Users must ensure they select the right scan protocol for their specific breathing pattern.
The MRI images acquired during treatment may not reflect the average anatomy position during breathing. The system doesn't show whether the scan used respiratory triggering, which could cause treatment errors if the wrong protocol is selected.
Medical professionals using Elekta Unity systems for radiation therapy with MRI. Those who rely on respiratory motion tracking for treatment planning are most at risk.
Check for the Unity system model numbers listed in the recall notice: 13553-006/600003, 13371-002/600021, and other specific codes mentioned in the product description.
Ensure you select the appropriate scan protocol that matches the respiratory phase used in your treatment plan to avoid image misalignment.
The images acquired using these protocols may not represent the average anatomy position during breathing, and the software doesn't indicate if respiratory triggering was used.
Check for the Unity system model numbers listed in the recall notice, such as 13553-006/600003 or 13371-002/600021.
Ensure you select the correct scan protocol that matches the respiratory phase used in your treatment plan to avoid potential treatment errors.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1109-2019 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1109-2019 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.
