BEUDAMED
    FDA Recall 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 · Initiated March 13, 2017

    Recall

    Recall Number
    Z-1768-2017
    Event Number
    76723
    Firm
    Nihon Kohden America Inc
    FEI Number
    2080783
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 13, 2017
    Posted
    March 20, 2017
    Terminated
    October 1, 2017
    Address
    15353 Barranca Pkwy, Irvine, CA, 92618-2216

    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.

    Action

    A technical bulletin was issued on March 7, 2017 to make Life Scope G9 users aware of following interaction: the CNS 6201A and CNS 9701A (using the noted software versions) will not Auto Resume when a patient is reconnected to a Life Scope G9 if the patient tile is Paused. Therefore, each time a patient is reconnected to the Life Scope G9, the Pause must be cancelled and monitoring manually resumed on the CNS 6201A or CNS 9701A. A customer letter dated March 13, 2017 was sent to all customers to inform them that Nihon Kohden America (NKA) is voluntarily notifying them that the Pause function on central monitors (models CNS 6201A and CNS 9701A; Software Versions 01-06, 02-10 and 02-40), will not automatically resume when connected to a Life Scope G9 patient monitor (model CSM 1901; versions 01-19, 01-20 and 01-21). Customers are informed of issue,risk to health, and instructions. Customers are instructed to complete the attached reply form and return it to the fax number or email address on the form. Customers with questions are instructed to contact NKA Technical Services Group at (800) 325-0283, Option 6 (M-F, 8am-5pm PDT) or by email at [email protected].

    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)