Elekta Medical Linear Accelerators: Electrical Grounding Hazard
Elekta recalls Synergy, Harmony, Infinity, and Versa HD linear accelerators due to electrical grounding issues. Affected units may have safety risks during medical treatments.
Use caution until it’s fixed
Due to a manufacturing issue and electrical grounding of systems.
Contact the company
What happened, in plain English
Elekta is recalling several types of medical linear accelerators because of electrical grounding problems. This could pose safety risks during radiation therapy treatments if the device malfunctions. Read more at govinfonow.com/recall/50459-elekta-medical-linear-accelerators-electrical-grounding-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/50459-elekta-medical-linear-accelerators-electrical-grounding-hazard · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1164-2026
Cite this page
“Elekta Medical Linear Accelerators: Electrical Grounding Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50459-elekta-medical-linear-accelerators-electrical-grounding-hazard. Based on FDA recall #Z-1164-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1164-2026%22&limit=1).
Why it’s dangerous
Electrical grounding issues could cause the device to malfunction during radiation therapy. This might lead to improper treatment delivery or safety hazards if the machine is not properly grounded.
Who’s affected
Patients receiving radiation therapy at medical facilities using these specific Elekta linear accelerators are most at risk. Healthcare providers and facilities that use these devices may also be affected.
How to tell if you have this one
Check for the product names: Elekta Synergy, Harmony, Infinity, or Versa HD. Look for specific lot codes listed in the recall notice, such as 05060191071550 for Synergy.
- Brand
Elekta- Category
Medical device
What to do — step by step
Check Device Lot Code
Identify the lot code on your device's label to confirm if it matches the recalled units listed in the notice.
Contact Your Facility
Reach out to your medical facility to determine if your device is affected and what steps they recommend.
How this recall unfolded
Recall timeline
FDA published this recall 52 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.
Questions people ask
How do I know if my device is affected?
Check the product name and lot code against the list provided in the recall notice: Synergy (lot 05060191071550), Harmony (lot 05060191071604), etc.
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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-1164-2026 (December 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1164-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.