BEUDAMED
    FDA Enforcement Class II Terminated

    Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 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 work flows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

    Recall: Z-0168-2018 · Reported November 29, 2017

    Enforcement

    Recall Number
    Z-0168-2018
    Event ID
    77456
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2017
    Initiation Date
    May 22, 2017
    Classification Date
    November 21, 2017
    Termination Date
    July 2, 2018
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 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 work flows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

    Reason

    Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that the number of de-archived images is less than the count of the archived images for the series. The issues were discovered through Siemens Global Complaint Handling System.

    Code Info

    non-medical software application Check Tool V1 .0 (L TA Incomplete Archive Check Tool V1 .0)

    Distribution

    Distribution to MN

    Quantity

    2 units