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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87011

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 21, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Nihon Kohden America Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0865-2021
Recall number
Z-0865-2021
Initiated
December 21, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Nihon Kohden America Inc
Quantity
189 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical device non-conformance to electrical safety standard (IEC 60601-1).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

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.