BEUDAMED
    FDA Recall 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 · Initiated June 21, 2013

    Recall

    Recall Number
    Z-1814-2013
    Event Number
    65666
    Firm
    Picis Inc.
    FEI Number
    3005244943
    Product Code
    NSX
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    June 21, 2013
    Posted
    July 29, 2013
    Terminated
    December 19, 2014
    Address
    100 Quannapowitt Parkway, Suite 405, Wakefield, MA, 01880

    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.

    Action

    Initial customer notifications were sent via email on June 21, 2013 informing consignees of the recall and providing further instruction regarding the software solution. Consignees were provided with recommended actions until they receive the necessary update.

    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