BEUDAMED
    FDA Enforcement Class II Terminated

    Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,

    Recall: Z-2088-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2088-2016
    Event ID
    74390
    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 6, 2016
    Initiation Date
    May 9, 2016
    Classification Date
    June 29, 2016
    Termination Date
    March 20, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,

    Reason

    Software error in previous software versions in which two references for the same image may exist in the database.

    Code Info

    Serial Numbers: 100389, 100198, 100258, 100259, 100538, 100133, 100213, 100214, 100031, 100484, 100362, 100233, 100140, 100141, 100142, 100143, 100144, 100416, 100105, 100106, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100119, 100120, 100457, 100245, 100447, 100364, 100314, 100298, 100299, 100386, 100139, 100027, 100300, 100197, 100025, 100084 100186, 100189, 100190, 100191, 100192, 100195, 100196, 100033, 100306, 100307, 100232, 100256, 100199, 100188, 100194, 100257, 100425, 100029, 100253, 100132, 100247, 100248, 100434, 100491, 100495, 100221, 100212

    Distribution

    US Distribution to the states of : AL, CA, CT, FL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX, WI

    Quantity

    74 systems