Reported Feb 3, 2021 · Ongoing
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI…
Nihon Kohden America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nihon Kohden America Inc · 90 Icon · Foothill Ranch, CA · 92610-3000
Is this the product you have?
- PSG-1100 Sleep Diagnostic System
- Sample product labelJB-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
- Lot codes and dates
Serial numbers 3. Serial numbers 3204705075346217577707958921165-11831186- 12051214-12931295-12971304-13301333-13421358 -13841387-13891391-14131421-14301434-15051507- 1516
- Amount recalled
- 189 Units
Where it was sold
Why it was recalled
Medical device non-conformance to electrical safety standard (IEC 60601-1).
This product could cause temporary or reversible health problems — stop using it.
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