Brainlab recalls ExacTrac Dynamic software models 20910-01E and 20910-01F (versions 1.1.0-1.1.1) due to potential DIBH functionality issues in radiation therapy workflows.
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Brainlab is recalling specific software versions for radiation therapy systems because the Deep Inspiration Breath Hold feature might not function properly during standard treatment templates. This could affect treatment accuracy if the software doesn't respond correctly to breathing patterns.
The software's Deep Inspiration Breath Hold feature may not work as intended when following standard treatment templates. This could lead to inaccurate radiation delivery if the system doesn't properly track breathing patterns during treatment.
Patients receiving radiation therapy using Brainlab ExacTrac systems with the recalled software versions are most at risk. Healthcare providers using these systems for treatment planning may also be affected.
Check if your Brainlab ExacTrac system has software versions 1.1.0 or 1.1.1. The product was sold with GTIN 04056481143978 and models 20910-01E or 20910-01F.
Verify your software version by checking the system settings or documentation for versions 1.1.0 or 1.1.1.
The recall indicates a potential issue with the Deep Inspiration Breath Hold feature in specific software versions, but the official notice does not state that this poses a risk of serious injury or death.
Your system is affected if it has software versions 1.1.0 or 1.1.1, models 20910-01E or 20910-01F, and the GTIN 04056481143978.
The recall does not specify a remedy, so no action is required beyond checking your software version.
We’ve drafted a message you can send Brainlab to request your refund or repair — edit it as you like.
Subject: Recall Z-1259-2023 — Brainlab Brainlab Hello, I own a Brainlab that is covered by recall Z-1259-2023 from Brainlab. 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.
