Elekta Unity Radiation Therapy System Recall: Low Risk of Overheating Connector
Elekta recalls Unity Image-Guided Radiation Therapy Systems with a potential overheating electrical connector in the MR gradient coil. This low-risk issue may require monitoring but does not mandate immediate action.
Lower-risk recall
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
Contact the company
What happened, in plain English
Elekta is recalling certain Unity Image-Guided Radiation Therapy Systems due to a low possibility of an electrical connector overheating in the MR gradient coil. This issue is unlikely to cause serious harm but should be monitored. Read more at govinfonow.com/recall/58603-elekta-unity-radiation-therapy-system-recall-low-risk-of-overheating.
Source Summary by GovInfoNow · govinfonow.com/recall/58603-elekta-unity-radiation-therapy-system-recall-low-risk-of-overheating · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1675-2023
Cite this page
“Elekta Unity Radiation Therapy System Recall: Low Risk of Overheating Connector.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58603-elekta-unity-radiation-therapy-system-recall-low-risk-of-overheating. Based on FDA recall #Z-1675-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1675-2023%22&limit=1).
Why it’s dangerous
The electrical connector in the MR gradient coil could overheat, though this is a low possibility. The overheating might cause a minor issue but is unlikely to lead to serious injury or damage.
Who’s affected
Healthcare facilities using Elekta Unity systems with specific serial numbers are affected. Medical professionals and patients using these systems are at the lowest risk due to the low possibility of overheating.
How to tell if you have this one
Check for the specific serial numbers listed in the recall notice: 14117-007/600034, 10632-010/600036, and other combinations provided in the recall record. This system is used in medical radiation therapy settings.
- Brand
Elekta- Product
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil- Category
Medical device
What to do — step by step
Check Serial Numbers
Verify if your system has the specific serial numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
FDA distribution: “US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Iowa, Kansas, Louisiana, Michigan, New Jersey, New Mexico, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Wisconsin.
Recall timeline
FDA published this recall 2 months 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
What should I do if I have this system?
Check the serial numbers against the list provided in the recall notice. If your system matches, monitor it for any issues.
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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-1675-2023 (April 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1675-2023 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.