BEUDAMED
    FDA Recall Terminated

    CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.

    Recall: Z-1979-2014 · Initiated June 3, 2014

    Recall

    Recall Number
    Z-1979-2014
    Event Number
    68459
    Firm
    Nihon Kohden America Inc
    FEI Number
    2080783
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 3, 2014
    Posted
    July 2, 2014
    Terminated
    April 28, 2015
    Address
    15353 Barranca Pkwy, Irvine, CA, 92618-2216

    Description

    CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.

    Reason

    Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate.

    Action

    Nihon Kohden sent an Urgent Medical Device Safety Notification and Field Correction letter dated June 3, 2014 to affected customers. Recall notification letter, dated June 3, 2014 was hand-delivered to site by Nihon personnel. The letter provided the following information: product description with codes and software version, reason for recall, field correction information and actions to be taken, MedWatch reporting information, and contact information for recall.

    Distribution

    Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa.

    Quantity

    430