Use cautionMedical device recall · FDA · Published December 18, 2019
Elekta Unity Radiation Therapy System Recall: Excessive Heating Risk
Elekta recalls specific Unity radiation therapy systems due to reported excessive heating in the MRL Gradient Connection Module. Affected units have serial numbers starting with 600014 to 600035. Contact Elekta for details.
“Elekta Unity Radiation Therapy System Recall: Excessive Heating Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66283-elekta-unity-radiation-therapy-system-recall-excessive-heating-risk. Based on FDA recall #Z-2473-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2473-2020%22&limit=1).
The FDA announced on 2019-12-18 that Elekta, Inc. voluntarily recalled its Elekta Unity Image-Guided Radiation Therapy Systems due to reports of excessive heating in the MRL Gradient Connection Module. The recall affects 21 devices distributed in the U.S. and internationally.
How to tell if you have it
Brand: Elekta
Product: Elekta Unity, Image-Guided Radiation Therapy System
The FDA stated there have been reports of excessive heating in the MRL Gradient Connection Module. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show Elekta, Inc. has 39 other recalls on record since 2017-06-19. Other recent recalls of similar products include the Elekta MOSAIQ Oncology System Software Recall (2026-05-21), the Elekta Fletcher CT/MR Shielded Applicator Set Recall (2026-04-03), and the Elekta Leksell Vantage Arc System Recall (2026-03-19). Other recent recalls of similar products include the I.T.S. DUL/UOL Systems Risk MRI Heating - Recall (2026-01-23) and Gentherm Blanketrol III Model 233 Thermal Regulator Overheating Risk (2026-07-13).
How to tell if you have this one
Check if your Elekta Unity system has a serial number between 600014 and 600035. The system is used in hospitals and medical facilities for radiation therapy treatments.
Brand
Elekta
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Identify your Elekta Unity system's serial number to see if it falls within the range 600014 to 600035.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distributed in US - PA, NY, and IA. Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK. There was no government/military distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Iowa, New York, Pennsylvania.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2473-2020 (December 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2473-2020 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.