BEUDAMED
    FDA Enforcement Class II Terminated

    SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.

    Recall: Z-1972-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1972-2015
    Event ID
    71507
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2015
    Initiation Date
    June 11, 2015
    Classification Date
    July 2, 2015
    Termination Date
    March 24, 2017
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406, United States

    Description

    SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.

    Reason

    During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.

    Code Info

    model number: 10014064 serial numbers: 5846 5847 4333 4334 4335

    Distribution

    US in the states of NC and NE

    Quantity

    5