Elekta recalls specific models of medical radiation therapy systems due to potential uncontrolled extension of detector arms if microswitch is incorrectly set up. Affected units include those with serial numbers listed in the recall notice.
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
Elekta is recalling certain models of medical radiation therapy systems that may have a microswitch setup error causing detector arms to extend uncontrollably. This could pose a risk during medical procedures if the arms extend unexpectedly.
If the microswitch in the middle arm is incorrectly configured, the detector arms (iViewGT/XVI) could extend uncontrollably. However, the risk only exists when the detector arm is fully deployed, and there is no risk if the arm is not fully extended.
Healthcare facilities using Elekta Synergy Platform models with serial numbers listed in the recall notice are most at risk. Patients receiving radiation therapy with these systems may be affected if the detector arms extend unexpectedly.
Check if your Elekta Synergy Platform has serial numbers listed in the recall notice, such as 152110, 153550, or UDI/DI 05060191071536. The product is a medical radiation therapy system used in hospitals.
Verify the microswitch in the middle arm is correctly configured to prevent uncontrolled detector arm extension.
The recall addresses a potential risk during medical procedures if detector arms extend uncontrollably, but the risk only occurs when the arm is fully deployed. Patients using the system should follow healthcare provider instructions.
Check if your Elekta Synergy Platform has serial numbers listed in the recall notice, such as 152110, 153550, or UDI/DI 05060191071536.
No, the recall does not require immediate discontinuation. The risk only exists if the detector arm is fully deployed, and the device is safe otherwise.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-0444-2024 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0444-2024 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.
