FDA-Device2015-05-06Class II
Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device will display physiological data from up to 16 telemetry receiver/transmitters or bedside monitors and generate an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmias are dete
Nihon Kohden America Inc
Hazard
Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
Sold states
US Distribution to states of: AL, CO, DE, FL, GA, HI, KY, IL, IN, MA, MD, MI, MN, MO, NC,, ND, NJ, NY.OH, PA, and WV.
Affected count
208 units
Manufactured in
15353 Barranca Pkwy, Irvine, CA, United States
Products
Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device will display physiological data from up to 16 telemetry receiver/transmitters or bedside monitors and generate an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmias are detected.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1543-2015Don't want to check this manually?
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