BEUDAMED
    FDA Enforcement Class II Terminated

    Syngo.plaza VB10A, Picture Archiving and Communication System

    Recall: Z-2892-2016 · Reported October 5, 2016

    Enforcement

    Recall Number
    Z-2892-2016
    Event ID
    75171
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2016
    Initiation Date
    September 6, 2016
    Classification Date
    September 27, 2016
    Termination Date
    May 8, 2017
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Syngo.plaza VB10A, Picture Archiving and Communication System

    Reason

    Software upgrade to eliminate several issues

    Code Info

    Serial Numbers: 100262 100198 100258 100259 100538 100133 100213 100214 100031 100484 100362 100416 100461 100457 100447 100139 100027 100559 100440 100441 100025 100084 100186 100189 100190 100191 100192 100195 100196 100033 100232 100449 100450 100199 100256 100228 100425 100029 100253 100203 100204 100132 100434 100491 100495 100206

    Distribution

    Distributed Nationwide

    Quantity

    47 systems