Nihon Kohden America Inc recalls Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is i…

Recall date

April 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1543-2015

FDA classification

Class II

Brand / firm

Nihon Kohden America Inc

Sold / distributed

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.

Why it was recalled

Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.