Jul

2014

Cl II Nihon CNS-6200 Series Central Nurse Station

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Nihon CNS-6200 Series Central Nurse Station

Amy Sellers

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