Elekta recalls specific models of medical linear accelerators due to a component non-compliant with IEC 60601 standards. Affected units include Elekta Infinity, Versa HD, and Elekta Synergy with specific serial numbers.
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
Elekta is recalling certain medical linear accelerators (Elekta Infinity, Versa HD, and Elekta Synergy) because a component in some units is non-compliant with IEC 60601 safety standards. This could pose a risk to patient safety during radiation therapy treatments.
The recall is for a component that does not meet IEC 60601 safety standards. This could potentially lead to device malfunction during radiation therapy, which might affect patient safety. However, the exact risk mechanism is not specified in the recall notice.
Healthcare facilities using Elekta medical linear accelerators with specific serial numbers are affected. Patients receiving radiation therapy with these devices may be at risk if the non-compliant component causes malfunction.
Check if your Elekta Infinity, Versa HD, or Elekta Synergy unit has the listed serial numbers or UDI-DI numbers. The specific serial numbers are provided in the recall notice for each model.
Review the serial numbers of your Elekta medical linear accelerator to see if they match the listed numbers in the recall notice.
The recall is because a component in a limited number of Elekta medical linear accelerators has been found non-compliant with IEC 60601 safety standards.
Affected models include Elekta Infinity, Versa HD, and Elekta Synergy with specific serial numbers listed in the recall notice.
The recall notice does not specify a remedy, so you should contact Elekta directly to determine next steps.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1665-2023 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1665-2023 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.
