Elekta Oncentra Brachy Version 4.0+ with License 170283-00: Dose Delivery Difference Risk
Elekta recalls Oncentra Brachy software versions 4.0 and above with specific Applicator Modeling license (170283-00) due to potential dose delivery differences between planned and actual radiation treatment.
Recall notice
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Contact the company
What happened, in plain English
Elekta recalls Oncentra Brachy software versions 4.0 and above that have the Applicator Modeling license 170283-00. This could cause differences in the radiation dose delivered to patients compared to what was planned, potentially affecting treatment accuracy. Read more at govinfonow.com/recall/61690-elekta-oncentra-brachy-version-4-0-with-license-170283-00.
Source Summary by GovInfoNow · govinfonow.com/recall/61690-elekta-oncentra-brachy-version-4-0-with-license-170283-00 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0182-2022
Cite this page
“Elekta Oncentra Brachy Version 4.0+ with License 170283-00: Dose Delivery Difference Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61690-elekta-oncentra-brachy-version-4-0-with-license-170283-00. Based on FDA recall #Z-0182-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0182-2022%22&limit=1).
Why it’s dangerous
The software may deliver a different radiation dose than intended for the two ovoid channels during treatment. This difference could affect the accuracy of radiation therapy, potentially leading to under or over-treatment of the target area.
Who’s affected
Patients receiving radiation therapy using this specific software version and license are most at risk. Healthcare providers using the Oncentra Brachy system with these software versions and licenses may also be affected.
How to tell if you have this one
Check if your Oncentra Brachy software is version 4.0 or higher with the Applicator Modeling license code 170283-00. The GTIN numbers listed in the recall notice can help identify affected units.
- Brand
Elekta- Product
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00- Category
Medical device
What to do — step by step
Check Software Version
Verify your Oncentra Brachy software version and Applicator Modeling license code to determine if it matches the recalled version (4.0+) with license 170283-00.
How this recall unfolded
Recall timeline
FDA published this recall 21 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.
Similar recalls
Latest medical device recalls
Keep exploring
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-0182-2022 (October 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0182-2022 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.