BEUDAMED
    FDA Enforcement Class II Terminated

    Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.

    Recall: Z-1280-2015 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-1280-2015
    Event ID
    70546
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2015
    Initiation Date
    January 23, 2015
    Classification Date
    March 16, 2015
    Termination Date
    April 20, 2017
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001, United States

    Description

    Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.

    Reason

    An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement

    Code Info

    6100F- PA00195 6100F- PA00197 6100F- PA00219 6100F- PA00221 6100F- PA00267 6100F- PA00269 6100F- PA00291 6100F- PA00293

    Distribution

    Nationwide Distribution

    Quantity

    519 units