Elekta Medical Linear Accelerators May Have Non-Compliant Component
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.
Recall notice
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/58455-elekta-medical-linear-accelerators-may-have-non-compliant-component.
Source Summary by GovInfoNow · govinfonow.com/recall/58455-elekta-medical-linear-accelerators-may-have-non-compliant-component · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1665-2023
Cite this page
“Elekta Medical Linear Accelerators May Have Non-Compliant Component.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58455-elekta-medical-linear-accelerators-may-have-non-compliant-component. Based on FDA recall #Z-1665-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1665-2023%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Elekta- Category
Medical device
What to do — step by step
Check Device Serial Numbers
Review the serial numbers of your Elekta medical linear accelerator to see if they match the listed numbers in the recall notice.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
FDA distribution: “Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA. International distribution to Belgium, Canada, Chile, China, France, Germany, India, Iraq, Italy, Jordan, Libyan Arab Jamahiriya, Mauritius, Mexico, Morocco, Poland,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, Indiana, Louisiana, Oklahoma, Tennessee, Virginia, Washington.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1665-2023 (May 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1665-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.