Elekta recalls specific models of Synergy radiation therapy systems with potential for 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 models of Synergy radiation therapy systems that could extend detector arms uncontrollably if the microswitch is incorrectly set up. This risk exists only when the detector arm is fully deployed, but it's important to ensure proper setup to prevent potential issues.
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. This means the hazard is conditional on improper setup.
Medical facilities using Elekta Synergy radiation therapy systems with the specific serial numbers listed in the recall notice are affected. Patients and staff at these facilities are at risk if the system is not properly configured.
Check if your Elekta Synergy system has the serial numbers listed in the recall notice (e.g., 154549, 151917, etc.). The product includes a UDI/DI code of 05060191071550.
Ensure the microswitch in the middle arm is correctly set up to prevent uncontrolled detector arm extension.
Yes, if the microswitch is incorrectly set up, there is a potential for uncontrolled extension of the detector arms.
Check if your Elekta Synergy system has the serial numbers listed in the recall notice (e.g., 154549, 151917, etc.).
Ensure the microswitch in the middle arm is correctly set up 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-0443-2024 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0443-2024 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.
