BEUDAMED
    FDA Enforcement Class II Terminated

    eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.

    Recall: Z-1557-2016 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1557-2016
    Event ID
    73673
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Visicu
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2016
    Initiation Date
    March 10, 2016
    Classification Date
    April 22, 2016
    Termination Date
    October 27, 2017
    Address
    217 E Redwood St Ste 1900, N/A, Baltimore, MD, 21202-3315, United States

    Description

    eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.

    Reason

    The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14 days later. An error message is generated and forwarded to operations. Subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement. If the pa

    Code Info

    453564506091 eCareCoordinator 1.3

    Distribution

    US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.

    Quantity

    9