Elekta recalls specific Versa HD models with potential uncontrolled detector arm extension if microswitch is incorrectly set up. Affected units have 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 Versa HD radiation therapy systems due to a risk that detector arms could extend uncontrollably if the microswitch is incorrectly configured. This could happen during use but only when the detector arm is fully deployed, which has no risk of extension.
If the microswitch in the middle arm is incorrectly set up, the detector arms could extend uncontrollably. However, when the detector arm is fully deployed, there is no risk of uncontrolled extension.
Medical facilities using Elekta Versa HD radiation therapy systems with the specific serial numbers listed in the recall notice are affected. Patients and staff at these facilities are most at risk during treatment procedures.
Check if your Elekta Versa HD system has the serial numbers listed in the recall notice. The affected models are identified by the UDI/DI 05060191071529 and 05060191071574.
Verify the microswitch in the middle arm is correctly configured to prevent uncontrolled detector arm extension.
The recall identifies a potential risk if the microswitch is incorrectly set up, but when the detector arm is fully deployed there is no risk of uncontrolled extension.
Check if your Elekta Versa HD system has the specific serial numbers listed in the recall notice.
Verify the microswitch setup to ensure it is correctly configured to prevent uncontrolled detector arm extension.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-0445-2024 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0445-2024 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.
