Company: Nihon Kohden America Inc
Date of Enforcement Report:6/25/2014
Class lI:
PRODUCT
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
Recall Number Z-1979-2014
REASON
Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate.
RECALLING FIRM/MANUFACTURER
Nihon Kohden America Inc Irvine, CA on 6/3/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
430
DISTRIBUTION
Oklahoma and Internationally
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