BEUDAMED
    FDA Enforcement Class II Terminated

    software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.

    Recall: Z-0826-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0826-2016
    Event ID
    73274
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    January 29, 2016
    Classification Date
    February 19, 2016
    Termination Date
    February 16, 2017
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.

    Reason

    Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.

    Code Info

    For model #10091673

    Distribution

    US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA and WI.

    Quantity

    151