FDA-Device2014-07-09Class II
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
Nihon Kohden America Inc
Hazard
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.
Sold states
Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa.
Affected count
430
Manufactured in
15353 Barranca Pkwy, Irvine, CA, United States
Products
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1979-2014Don't want to check this manually?
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