CLASS II ONGOING Device recall · Reported 3 Feb 2021 · FDA Enforcement Report
PSG-1100 Sleep Diagnostic System recalled by Nihon Kohden America
Nihon Kohden America is recalling PSG-1100 Sleep Diagnostic System, distributed nationwide in the US. The recall was initiated on 21 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0865-2021
- FDA event ID
- 87011
- Recalling firm
- Nihon Kohden America, Foothill Ranch, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Dec 2020
- FDA classified
- 14 Jan 2021
- Reported
- 3 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Dec 2020 | Recall initiated by company | |
| 14 Jan 2021 | Classified by FDA | +24 days |
| 3 Feb 2021 | Published in enforcement report | +20 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide CaliforniaColoradoConnecticutFloridaIdahoIllinoisIndianaMassachusettsMarylandMichiganMissouriNorth CarolinaNew MexicoNew YorkSouth CarolinaTennesseeTexasUtahVirginiaVermont
Questions about this recall
Why was it recalled?
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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