Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. Recalled by Nihon Kohden America Inc Due to Medical device non-conformance to electrical safety standard (IEC...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nihon Kohden America Inc directly.
Affected Products
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.
Quantity: 189 Units
Why Was This Recalled?
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nihon Kohden America Inc
Nihon Kohden America Inc has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report