Recall Z-1543-2015— Nihon Kohden America Inc
Class II · Terminated
Class II FDA medical device recall by Nihon Kohden America Inc, initiated 2015-04-14, terminated 2015-10-01. It names one FDA 510(k) clearance: K023475. 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.. Reason: Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound..
- Recalling firm
- Nihon Kohden America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-14
- Terminated
- 2015-10-01
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
Data sourced from openFDA. This site is unofficial and independent of the FDA.