BEUDAMED
    FDA Enforcement Class II Terminated

    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).

    Recall: Z-1768-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1768-2017
    Event ID
    76723
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nihon Kohden America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    March 13, 2017
    Classification Date
    April 10, 2017
    Termination Date
    October 1, 2017
    Address
    15353 Barranca Pkwy, N/A, Irvine, CA, 92618-2216, United States

    Description

    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).

    Reason

    The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.

    Code Info

    Lot/Unit Codes: G9 Serial Number: 230 (UDI: 01049319211121682100230) Serial Number: 232 (UDI: 01049319211121682100232) Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-6201A (PU-621RA) with version 01-06, 02-10, or 02-40 software. Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-9701A (MU-971RA) with version 01-89 or lower.

    Distribution

    Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Africa, Tunisia, United Arab Emirates, Korea, Malaysia, Singapore, Thailand

    Quantity

    654 units total (230 units in US)