10 results
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44ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
FDA Recall
Terminated
·Nihon Kohden America Inc·Product code MHX·June 3, 2014
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
FDA Recall
Terminated
·Nihon Kohden America Inc·Product code GWF·January 19, 2012
AG-920RA Multi-gas unit analyzer
FDA Recall
Terminated
·Nihon Kohden America Inc·Product code CCK·December 5, 2003
Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System)
FDA Recall
Terminated
·Nihon Kohden America Inc·Product code GWF·August 23, 2006
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
FDA Recall
Terminated
·Nihon Kohden America Inc·Product code MHX·March 13, 2017
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.
FDA Recall
Terminated
·Nihon Kohden America Inc·Product code MHX·April 14, 2015
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
FDA Enforcement
Class II
·Terminated·Nihon Kohden America Inc·July 9, 2014
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
FDA Enforcement
Class II
·Terminated·Nihon Kohden America Inc·February 24, 2016
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.
FDA Enforcement
Class II
·Terminated·Nihon Kohden America Inc·May 6, 2015
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
FDA Enforcement
Class II
·Terminated·Nihon Kohden America Inc·April 19, 2017