Elekta Oncentra Brachy Software Recall: Reconstruction Error Risk
Elekta recalls Oncentra Brachy radiation therapy software versions 4.0+ with reconstruction errors in Catheter Bending features. Affected units have specific UDI GTIN numbers listed. No remedy provided in official notice.
Recall notice
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Contact the company
What happened, in plain English
Elekta is recalling its Oncentra Brachy radiation therapy planning software versions 4.0 and above due to a potential reconstruction error when using the Catheter Bending feature. This could affect treatment planning accuracy for radiation therapy procedures. Read more at govinfonow.com/recall/59242-elekta-oncentra-brachy-software-recall-reconstruction-error-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/59242-elekta-oncentra-brachy-software-recall-reconstruction-error-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0719-2023
Cite this page
“Elekta Oncentra Brachy Software Recall: Reconstruction Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59242-elekta-oncentra-brachy-software-recall-reconstruction-error-risk. Based on FDA recall #Z-0719-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0719-2023%22&limit=1).
Why it’s dangerous
The software may produce incorrect reconstruction results when users apply the Catheter Bending functionality in Applicator or Implant Modeling. This could lead to inaccurate radiation treatment planning, potentially affecting patient safety during procedures.
Who’s affected
Medical professionals using Elekta's Oncentra Brachy software for radiation therapy planning are most at risk. Patients receiving treatment with affected software versions may also be impacted.
How to tell if you have this one
Check if you have Oncentra Brachy software version 4.0 or higher with Applicator Modeling or Implant Modeling features. Affected units have specific UDI GTIN numbers listed in the recall notice.
- Brand
Elekta- Product
Oncentra Brachy radiation therapy planning system software- Category
Medical device
What to do — step by step
Check Software Version
Verify your software version by checking the version number in the application settings or documentation.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distribution US nationwide, including Puerto Rico. There was no military/government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 16 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.
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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-0719-2023 (December 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0719-2023 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.