# FDA recall Z-1082-2019

> **Brainlab AG** · Class I · device recall initiated 2019-02-27.

## Product

Spine & Trauma 3D Navigation 1.0 (subpart of the system  Navigation Software Spine & Trauma 3D, Version 3.0 )     Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.

## Reason for recall

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.

## 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, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand and United Kingdom.

## Key facts

- **Recall number:** Z-1082-2019
- **Recalling firm:** Brainlab AG
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-27
- **Report date:** 2019-04-24
- **Termination date:** 2019-07-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1082-2019

## Citation

> AI Analytics. FDA recall Z-1082-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1082-2019. Source: US FDA. Licensed CC0.

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