BEUDAMED
    FDA Enforcement Class II Terminated

    Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.

    Recall: Z-1814-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1814-2013
    Event ID
    65666
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Picis Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 7, 2013
    Initiation Date
    June 21, 2013
    Classification Date
    July 29, 2013
    Termination Date
    December 19, 2014
    Address
    100 Quannapowitt Parkway, Suite 405, Wakefield, MA, 01880, United States

    Description

    Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.

    Reason

    Notes associated with prescription are not printed to the prescription or to the patient chart.

    Code Info

    Software Versions 5.2 and 5.3

    Distribution

    Nationwide Distribution, including the states of: AK, AR, AZ, CA, CO, DC, DE, FL, GA, ID, IN, MA, MD, MO, NH, NJ, OH, OR, SC, TN, WA, and WV.

    Quantity

    35