Brainlab recalls specific RT Elements software versions (1.0.0 and 1.5.0) for cranial, spine, and multiple brain mets SRS applications due to potential incorrect dose distribution calculations when using Pencil Beam algorithm on GPU.
There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting.
Brainlab is recalling specific versions of their RT Elements software for radiation treatment planning. These versions (1.0.0 and 1.5.0) could cause incorrect dose calculations when using the Pencil Beam algorithm on the default GPU settings, potentially leading to unsafe radiation treatment plans.
The software may calculate radiation doses incorrectly when using the Pencil Beam algorithm on the default GPU (graphics card) settings. This could lead to improper radiation treatment planning for patients, potentially causing under or over-dosing.
Healthcare professionals using Brainlab RT Elements software for radiation treatment planning of cranial, head/neck, and extracranial lesions are affected. Patients receiving treatment with these specific software versions are at risk of incorrect radiation dosing.
Check if your RT Elements software version is Cranial SRS 1.0.0/1.5.0, Spine SRS 1.0.0/1.5.0, Multiple Brain Mets SRS 1.5.0, or RT QA 1.0.0/1.5.0. The software is used for radiation treatment planning in hospitals and clinics.
Verify your RT Elements software version by checking the version numbers listed in the recall notice for affected applications.
Install the corrected software version from Brainlab's official website to fix the dose calculation issue.
Cranial SRS 1.0.0 and 1.5.0, Spine SRS 1.0.0 and 1.5.0, Multiple Brain Mets SRS 1.5.0, and RT QA 1.0.0 and 1.5.0.
Check your software version numbers against the specific versions listed in the recall notice for cranial, spine, and multiple brain mets SRS applications.
No, but you should update to the corrected software version to prevent potential incorrect dose calculations.
We’ve drafted a message you can send Brainlab to request your refund or repair — edit it as you like.
Subject: Recall Z-1205-2019 — Brainlab Brainlab Hello, I own a Brainlab that is covered by recall Z-1205-2019 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.
