# FDA recall Z-0430-2021

> **Stereotaxis Inc** · Class II · device recall initiated 2020-09-21.

## Product

Niobe ES System, Models 001-006000-1 and 001-006100-1

## Reason for recall

There is a potential for fire in the inside computer cabinet.

## Distribution

US and OUS distribution:  US - TN, MI, MN, KY, MO, IN, TX, NM, CA, NE, OH, NJ, CT, KS, OR, WA, WI, FL, IL, UT, PA, AZ, NY, GA, ID, OK, CO, LA    OUS - EU, China, Australia, Singapore, Canada, South Africa, and Japan

## Key facts

- **Recall number:** Z-0430-2021
- **Recalling firm:** Stereotaxis Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-21
- **Report date:** 2020-11-18
- **Termination date:** 2023-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Louis, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0430-2021

## Citation

> AI Analytics. FDA recall Z-0430-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0430-2021. Source: US FDA. Licensed CC0.

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