Brainlab recalls Spine & Trauma 3D Navigation 1.0 software due to potential navigation errors during surgery. Affected units may show incorrect instrument positions, risking surgical errors. Contact for remedy.
In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.
Brainlab is recalling a specific version of its Spine & Trauma 3D Navigation software because it can display incorrect instrument positions during surgery. This could lead to surgeons being unable to see where instruments are placed, potentially causing errors in spinal procedures.
The software might show an outdated view of the surgical area instead of the correct real-time view. This could make it difficult for surgeons to track instrument positions during spinal surgery, increasing the chance of errors.
Surgeons using the Spine & Trauma 3D Navigation 1.0 software version for spinal procedures are most at risk. Patients undergoing spinal surgery with this specific software version may be affected.
Check for the software version 1.0.0.249 labeled as 'Spine & Trauma 3D Navigation 1.0' in the system. This version was sold with the product GTIN 04056481140328.
Verify the software version is 1.0.0.249 by checking the system settings.
The software might display incorrect instrument positions during surgery, which could lead to navigation errors. However, the recall does not specify a risk of serious injury.
Look for the software version 1.0.0.249 labeled as 'Spine & Trauma 3D Navigation 1.0' with GTIN 04056481140328.
The recall does not specify a remedy, so contact Brainlab directly for guidance.
We’ve drafted a message you can send Brainlab to request your refund or repair — edit it as you like.
Subject: Recall Z-1082-2019 — Brainlab Brainlab Hello, I own a Brainlab that is covered by recall Z-1082-2019 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.
