Nucletron Oncentra Brachy 4.5 Software Recall: Incorrect Source Step Size Risk
Nucletron recalls Oncentra Brachy 4.5 radiation therapy software versions 4.5, 4.5.1, and 4.5.2 due to potential incorrect source step size in treatment plans.
Lower-risk recall
Incorrect source step size may occur in the software plans
Contact the company
What happened, in plain English
Nucletron is recalling specific versions of its Oncentra Brachy 4.5 radiation therapy software. This recall is due to a potential risk of incorrect source step size in treatment plans, which could affect radiation therapy accuracy. Read more at govinfonow.com/recall/73150-nucletron-oncentra-brachy-4-5-software-recall-incorrect-source-step.
Source Summary by GovInfoNow · govinfonow.com/recall/73150-nucletron-oncentra-brachy-4-5-software-recall-incorrect-source-step · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0050-2018
Cite this page
“Nucletron Oncentra Brachy 4.5 Software Recall: Incorrect Source Step Size Risk.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73150-nucletron-oncentra-brachy-4-5-software-recall-incorrect-source-step. Based on FDA recall #Z-0050-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0050-2018%22&limit=1).
Why it’s dangerous
The software may calculate incorrect source step sizes in radiation treatment plans. This could lead to inaccurate radiation dose distributions, potentially affecting treatment effectiveness or safety. However, the recall does not specify a risk of serious injury in normal use.
Who’s affected
Healthcare providers using the recalled software versions for radiation therapy planning are affected. Patients receiving treatment through these software versions may be at risk if the software error impacts treatment accuracy.
How to tell if you have this one
Check for software versions 4.5, 4.5.1, or 4.5.2 on the label. The product is used for radiation therapy planning in cancer treatment.
- Brand
Nucletron- Category
Medical device
What to do — step by step
Check Software Version
Verify the software version on your label to see if it is 4.5, 4.5.1, or 4.5.2.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.3 years 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.
Questions people ask
What should I do if I have the recalled software?
Check your software version to see if it is one of the recalled versions. If so, you may need to contact Nucletron for further instructions.
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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-0050-2018 (August 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0050-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.