# FDA recall Z-0031-2022

> **NOX MEDICAL** · Class II · device recall initiated 2021-09-07.

## Product

Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

## Reason for recall

Error in the device firmware results in the inaccurate detection of device position.

## Distribution

US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD.

## Key facts

- **Recall number:** Z-0031-2022
- **Recalling firm:** NOX MEDICAL
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-07
- **Report date:** 2021-10-13
- **Termination date:** 2023-05-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reykjavik, Iceland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0031-2022

## Citation

> AI Analytics. FDA recall Z-0031-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0031-2022. Source: US FDA. Licensed CC0.

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