Use caution Medical device recall · FDA · Published February 27, 2019

Brainlab Spine & Trauma 3D Navigation Software Recalled: May Cause Navigation Errors

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1082-2019Medical device Brainlab ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmBrainlab AGOlof-palme-str. 9 · Munich, Germany

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/68932-brainlab-spine-trauma-3d-navigation-software-recalled-may-cause-navigation.

Source Summary by GovInfoNow · govinfonow.com/recall/68932-brainlab-spine-trauma-3d-navigation-software-recalled-may-cause-navigation · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1082-2019

Cite this page

“Brainlab Spine & Trauma 3D Navigation Software Recalled: May Cause Navigation Errors.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68932-brainlab-spine-trauma-3d-navigation-software-recalled-may-cause-navigation. Based on FDA recall #Z-1082-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1082-2019%22&limit=1).

The FDA announced on Feb. 27, 2019, that Brainlab AG voluntarily recalled its Spine & Trauma 3D Navigation software due to a hazard where the application might display an incorrect view representation. This error could prevent surgeons from determining the position of navigated instruments during spine procedures.

How to tell if you have it

Brand: Brainlab
Product: Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended
UPC: 04056481140328

The hazard

The software might unexpectedly display a navigated instrument in an axial, coronal/sagittal view with fixed planes instead of the desired inline view. This could occur after a crash restore or when changing navigation workflows during treatment. The record states this might lead the surgeon to be unable to determine the position of the navigated instrument.

Context

GovInfoNow's records show Brainlab AG has 15 other recalls on record since July 28, 2017. Recent similar recalls include the Brainlab Origin Data Management Software recall (Feb. 10, 2025), the Brainlab Cirq Arm System 2.0 recall (March 2, 2023), and the Brainlab ExacTrac Software recall (Feb. 14, 2023). Other recent recalls of similar products include the GE Medical Systems Imactis CT-Navigation System recall (Feb. 3, 2026), the Mazor X Robotic System software errors risk incorrect spinal surgery recall (Dec. 10, 2025), and the Intuitive Surgical da Vinci 5 Console Display recall (Dec. 30, 2025).

How to tell if you have this one

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.

Brand
Brainlab
Product
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version is 1.0.0.249 by checking the system settings.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide Distribution: US (Nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Kazakhstan, Malaysia, New Zealand, Philippines,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 4 months after the firm started it.

Feb 27, 2019Firm started the recall
Apr 15, 2019FDA classified it Class I
Apr 24, 2019Published in FDA’s Enforcement Report
Jul 10, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/68932-brainlab-spine-trauma-3d-navigation-software-recalled-may-cause-navigation">Brainlab Spine &amp; Trauma 3D Navigation Software Recalled: May Cause Navigation Errors (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1082-2019 (February 27, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1082-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.