Recall Z-0865-2021— Nihon Kohden America Inc
Class II · Ongoing
Class II FDA medical device recall by Nihon Kohden America Inc, initiated 2020-12-21. It names one FDA 510(k) clearance: K120888. 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)..
- Recalling firm
- Nihon Kohden America Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-12-21
- Firm location
- Foothill Ranch, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Data sourced from openFDA. This site is unofficial and independent of the FDA.