# FDA recall Z-0118-2022

> **MEDTECH SAS** · Class I · device recall initiated 2021-09-22.

## Product

ROSA One 3.1 Brain application    The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.

## Reason for recall

The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.

## Distribution

US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands.

## Key facts

- **Recall number:** Z-0118-2022
- **Recalling firm:** MEDTECH SAS
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-22
- **Report date:** 2021-11-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Montpellier, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2022

## Citation

> AI Analytics. FDA recall Z-0118-2022. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-0118-2022. Source: US FDA. Licensed CC0.

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