BEUDAMED
    FDA Enforcement Class II Terminated

    Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is 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. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

    Recall: Z-0524-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0524-2018
    Event ID
    78677
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2018
    Initiation Date
    August 23, 2017
    Classification Date
    February 5, 2018
    Termination Date
    October 1, 2018
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is 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. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

    Reason

    When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow Step and not show in all other workflow steps. The other workflow steps will continue to show the initially loaded study.

    Code Info

    Model Number - 10863171, 10863172, 10863173

    Distribution

    US Nationwide Distribution

    Quantity

    76