# FDA recall Z-0056-2021

> **Brainlab AG** · Class II · device recall initiated 2020-08-31.

## Product

Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage:  intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

## Reason for recall

Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of Illinois, Massachusetts, Texas, California, Idaho, Missouri, Oregon, Connecticut and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Curacao, Czech Republic, Egypt, Finland, France, Germany, Switzerland, Netherlands, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kuwait, Malaysia, Myanmar, Norway, Pakistan, Romania, Slovakia, South Africa, Spain, Sweden, Thailand, Turkey and United Kingdom.

## Key facts

- **Recall number:** Z-0056-2021
- **Recalling firm:** Brainlab AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-31
- **Report date:** 2020-10-14
- **Termination date:** 2021-02-17

- **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-0056-2021

## Citation

> AI Analytics. FDA recall Z-0056-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0056-2021. Source: US FDA. Licensed CC0.

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