BEUDAMED
    FDA Enforcement Class II Terminated

    Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.

    Recall: Z-1354-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1354-2015
    Event ID
    70596
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    February 18, 2015
    Classification Date
    March 30, 2015
    Termination Date
    August 17, 2016
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355-1406, United States

    Description

    Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.

    Reason

    Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.

    Code Info

    Model Numbers of device: 10592457, 10863172, serial numbers: 100177 100033 100181 100029

    Distribution

    US Distribution: MA, WI, FL

    Quantity

    4