Nihon Kohden PSG-1100 Sleep Diagnostic System Recalled for Electrical Safety Non-Conformance
Nihon Kohden America Inc is recalling 189 PSG-1100 Sleep Diagnostic Systems because they do not meet the IEC 60601-1 electrical safety standard.
- 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…
- Category
- Medical Device
- Distribution
- Distributed nationwide