Elekta Unity radiation therapy system recall: Legionella risk in heat exchanger
Elekta recalls Unity radiation therapy systems with serial numbers 600001-600043 due to potential Legionella in heat exchanger condensation tray. Affected units may need cleaning or inspection.
Lower-risk recall
potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
Contact the company
What happened, in plain English
Elekta is recalling specific Unity radiation therapy systems that could have Legionella bacteria in the heat exchanger condensation tray. This poses a risk of Legionella infection if the water in the tray becomes contaminated and is inhaled. Read more at govinfonow.com/recall/65263-elekta-unity-radiation-therapy-system-recall-legionella-risk-in-heat.
Source Summary by GovInfoNow · govinfonow.com/recall/65263-elekta-unity-radiation-therapy-system-recall-legionella-risk-in-heat · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2289-2020
Cite this page
“Elekta Unity radiation therapy system recall: Legionella risk in heat exchanger.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65263-elekta-unity-radiation-therapy-system-recall-legionella-risk-in-heat. Based on FDA recall #Z-2289-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2289-2020%22&limit=1).
Why it’s dangerous
Legionella bacteria can grow in warm, stagnant water. If the condensation water in the heat exchanger tray becomes contaminated and is inhaled, it could cause Legionella infection, a type of bacterial pneumonia.
Who’s affected
Medical facilities using Elekta Unity systems with serial numbers 600001-600043 are likely affected. Staff handling the equipment or patients using the system are at risk if Legionella contamination occurs.
How to tell if you have this one
Check for serial numbers 600001 to 600043 on the Elekta Unity radiation therapy system. The product is used for radiation therapy treatments and stereotactic treatments of cancer and other diseases.
- Brand
Elekta- Category
Medical device
What to do — step by step
Check Serial Numbers
Look for serial numbers 600001 to 600043 on the Elekta Unity system.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of PA, WI, NY, TN, NJ, IA, TX, and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Iowa, New Jersey, New York, Pennsylvania, Tennessee, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-2289-2020 (April 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2289-2020 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.