PSG-1100 Sleep Diagnostic System — Class II medical device recall Z-0865-2021
Ongoing recall by Nihon Kohden America Inc, reported 2021-02-03, distributed nationwide. Medical device non-conformance to electrical safety standard (IEC 60601-1).
| Recall number | Z-0865-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nihon Kohden America Inc, Foothill Ranch, CA, United States |
| Recall initiated | 2020-12-21 |
| Classified | 2021-01-14 |
| Reported by FDA | 2021-02-03 |
| Distributed | Nationwide (US) |
| Quantity | 189 units |
| UPC / GTIN / UDI-DI | 04931921108383 |
| Serial numbers | 01454, 1165-1183, 1186, 1205, 1214-1293, 1295-1297, 1304-1330, 1333-1342, 1358, 1384, 1387-1389, 1391-1413, 1421-1430, 1434-1505, 1507, 1516, 320, 470, 507, 534, 621, 757, 770, 795, 892 |
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0865-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.