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.
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
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.
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.
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.
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.
Verify your software version by checking the version number in the application settings or documentation.
The official recall notice does not provide a remedy for this issue.
Software versions 4.0 and above with Applicator Modeling or Implant Modeling features.
Check the UDI GTIN numbers listed in the recall notice: 08717213052758, 08717213038660, 08717213020610, and other specific numbers provided in the notice.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-0719-2023 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0719-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
