FDA Device recall Z-0865-2021
PSG-1100 Sleep Diagnostic System
- FDA Device
- Class II
- ongoing
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of PSG-1100 Sleep Diagnostic System by Nihon Kohden America, citing medical device non-conformance to electrical safety standard (IEC 60601-1).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0865-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-21 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nihon Kohden America |
| Distribution | US |
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
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Identifiers
| code_info | Serial numbers 3. Serial numbers 320, 470, 507, 534, 621, 757, 770, 795, 892, 1165-1183, 1186- 1205, 1214-1293, 1295-…Serial numbers 3. Serial numbers 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0865-2021%22
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