# FDA recall Z-0865-2021

> **Nihon Kohden America Inc** · Class II · device recall initiated 2020-12-21.

## Product

PSG-1100 Sleep Diagnostic System.    Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan    The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.

## Reason for recall

Medical device non-conformance to electrical safety standard (IEC 60601-1).

## Distribution

US Nationwide Distribution - CA, CO, CT, FL, ID, IL, IN, MA, MD, MI, MO, NC, NM, NY, SC, TX, TN, UT, VA, VT and WA.

## Key facts

- **Recall number:** Z-0865-2021
- **Recalling firm:** Nihon Kohden America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-12-21
- **Report date:** 2021-02-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Foothill Ranch, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0865-2021

## Citation

> AI Analytics. FDA recall Z-0865-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0865-2021. Source: US FDA. Licensed CC0.

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