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.
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
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.
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.
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.
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.
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.
The recall is due to a potential difference between the planned and delivered radiation dose for the two ovoid channels, which could affect treatment accuracy.
Check if your software version and license match the recalled version (4.0+ with license 170283-00). If so, contact Elekta for further instructions.
The recall indicates a potential difference in radiation dose delivery, which could affect treatment accuracy but does not specify immediate safety risks like injury or death.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-0182-2022 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0182-2022 from Elekta. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
