Elekta recalls specific models of Infinity radiation therapy systems due to potential uncontrolled extension of detector arms if microswitch is incorrectly set up. Affected units include serial numbers starting with 152596 to 154565.
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 Infinity radiation therapy systems that may have a microswitch issue causing detector arms to extend uncontrollably. This could pose a risk during medical procedures if the arms are not properly secured.
If the microswitch in the middle arm is incorrectly set up, the detector arms could extend uncontrollably during use. However, the hazard only occurs when the arms are fully deployed and there is no risk of extension when the detector arm is fully deployed.
Medical facilities using Elekta Infinity radiation therapy systems with specific serial numbers listed in the recall notice are most at risk. Patients undergoing treatment with these systems may need to be monitored for potential complications.
Check if your Elekta Infinity system has serial numbers listed in the recall notice (e.g., 152596 to 154565). The product is a medical radiation therapy system used for cancer treatment.
Verify if your Elekta Infinity system has a serial number listed in the recall notice (e.g., 152596 to 154565).
The recall identifies a potential risk if the microswitch is incorrectly set up, but the hazard only occurs when the detector arms are fully deployed and there is no risk of extension when fully deployed.
Check your system's serial number against the list provided in the recall notice. If it matches, contact Elekta for further instructions.
Look for serial numbers starting with 152596 to 154565 as listed in the recall notice.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-0446-2024 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0446-2024 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.
