Use caution Medical device recall · FDA · Published December 21, 2020

Nihon Kohden PSG-1100 Sleep Diagnostic System Recall: Electrical Safety Hazard

Nihon Kohden recalls PSG-1100 Sleep Diagnostic Systems with specific serial numbers due to electrical safety non-conformance with IEC 60601-1 standards. Affected units may pose a risk of electrical shock during sleep studies.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0865-2021Medical device Nihon Kohden ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmNihon Kohden America Inc90 Icon · Foothill Ranch, CA 92610-3000

✎ GovInfoNow plain-language explainer

Nihon Kohden is recalling certain PSG-1100 Sleep Diagnostic Systems because they don't meet electrical safety standards. This could lead to electrical shock during sleep studies, which is a serious risk for users. Read more at govinfonow.com/recall/63632-nihon-kohden-psg-1100-sleep-diagnostic-system-recall-electrical-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/63632-nihon-kohden-psg-1100-sleep-diagnostic-system-recall-electrical-safety · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0865-2021

Cite this page

“Nihon Kohden PSG-1100 Sleep Diagnostic System Recall: Electrical Safety Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63632-nihon-kohden-psg-1100-sleep-diagnostic-system-recall-electrical-safety. Based on FDA recall #Z-0865-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0865-2021%22&limit=1).

The FDA announced on Dec. 21, 2020, that Nihon Kohden America Inc is recalling the PSG-1100 Sleep Diagnostic System due to non-conformance with electrical safety standards. The agency said the recall addresses a potential hazard associated with the device's electrical safety.

How to tell if you have it

Nihon Kohden PSG-1100 Sleep Diagnostic System
Serial numbers: 3, 320, 470, 507, 534, 621, 757, 770, 795, 892, 1165-1183, 1186-1205, 1214-1293, 1295-1297, 1304-1330, 1333-1342, 1358-1384, 1387-1389, 1391-1413, 1421-1430, 1434-1505, 1507-1516
UDI: (01) 04931921108383

The hazard

According to the FDA, the PSG-1100 Sleep Diagnostic System does not conform to the electrical safety standard IEC 60601-1. The record states this non-conformance constitutes the hazard but reports no specific incidents or injuries.

Context

GovInfoNow's records show Nihon Kohden America Inc has had four other recalls since Jan. 8, 2021, including a Sept. 18, 2024 recall for forehead SpO2 sensors due to FDA approval issues and an April 29, 2024 recall for the BSM-3000 Bedside Monitor regarding false alarms. Other recent recalls of similar products include the Philips Allura Xper FD10C Medical System (Dec. 15, 2025) for electrical short-circuit risk and the Stryker Neptune Smart Docking Station (May 6, 2026) for electrical shock risk.

How to tell if you have this one

Check the product label for serial numbers listed in the recall: 320, 470, 507, 534, 621, 757, 770, 795, 892, 1165-1183, 1186-1205, 1214-1293, 1295-1297, 1304-1330, 1333-1342, 1358-1384, 1387-1389, 1391-1413, 1421-1430, 1434-1505, 1507-1516.

Brand
Nihon Kohden
Product
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the serial number on the product label to determine if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 21 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Maryland, Massachusetts, Michigan, Missouri, New Mexico, New York, North Carolina, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington.

Recall timeline

FDA published this recall 44 days after the firm started it.

Dec 21, 2020Firm started the recall
Jan 14, 2021FDA classified it Class II
Feb 3, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63632-nihon-kohden-psg-1100-sleep-diagnostic-system-recall-electrical-safety">Nihon Kohden PSG-1100 Sleep Diagnostic System Recall: Electrical Safety Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0865-2021 (December 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0865-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.