BEUDAMED
    FDA Recall Terminated

    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: Z-1543-2015 · Initiated April 14, 2015

    Recall

    Recall Number
    Z-1543-2015
    Event Number
    71015
    Firm
    Nihon Kohden America Inc
    FEI Number
    2080783
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 14, 2015
    Posted
    April 29, 2015
    Terminated
    October 1, 2015
    Address
    15353 Barranca Pkwy, Irvine, CA, 92618-2216

    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

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

    Action

    The firm, Nihon Kohden, sent an Urgent Medical Device Alert" letter dated 4/14 /15 to customers. The letter describes the product, problem and actions to be taken. The customers were instructed to stop using the RNS for primary alarm notification and instead utilize the CNS and or the Bedside monitor for primary alarm notification, until such time NKA can provide corrective measures to your facility; Inform potential users in your organization of this notification, and complete the attached reply form and return it by fax (949) 580-1550 or email it to [email protected]. Customers with questions are instructed to contact NKA Technical Support Center at (800) 325-0283 Ext 6 (available 24 hours a day/7 days/week).

    Distribution

    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.

    Quantity

    208 units