BEUDAMED
    FDA Enforcement Class II Terminated

    Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.

    Recall: Z-0810-2014 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0810-2014
    Event ID
    66996
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medrad Mr Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2014
    Initiation Date
    November 21, 2013
    Classification Date
    January 23, 2014
    Termination Date
    March 30, 2015
    Address
    100 Global View Dr, Warrendale, PA, 15086-7601, United States

    Description

    Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.

    Reason

    The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs information from the monitor.

    Code Info

    P/N 301641, Catalog #s 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, 3014268W, with multiple serial numbers.

    Distribution

    Worldwide Distribution: US (nationwide) and Internationally to: Canada.

    Quantity

    922 units