Company: Nihon Kohden America Inc.
Date of Enforcement Report: 5/6/2015
Class lI:
PRODUCT
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.
Recall Number Z-1543-2015
REASON
Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
RECALLING FIRM/MANUFACTURER
Nihon Kohden America Inc, Irvine, CA on 4/14/2015. Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
208 units
DISTRIBUTION
Nationwide
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