BEUDAMED
    FDA Enforcement Class II Terminated

    Syngo.plaza, picture archiving and communications system.

    Recall: Z-1116-2017 · Reported February 8, 2017

    Enforcement

    Recall Number
    Z-1116-2017
    Event ID
    76278
    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 8, 2017
    Initiation Date
    January 11, 2017
    Classification Date
    January 31, 2017
    Termination Date
    November 16, 2017
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Syngo.plaza, picture archiving and communications system.

    Reason

    Software update for improvements and to resolve several issues

    Code Info

    Model Number: 10863171, 10863172, 10863173 Serial Numbers: 100262 100198 100258 100259 100135 100538 100133 100031 100105 100106 100109 100110 100111 100112 100113 100114 100115 100116 100117 100119 100120 100416 100461 100245 100447 100364 100298 100299 100386 100139 100027 100440 100441 100559 100025 100033 100196 100189 100190 100191 100192 100195 100186 100232 100450 100449 100256 100199 100188 100194 100198 100029 100253 100203 100204 100132 100139 100434 100476 100495 100491 100206

    Distribution

    Distributed throughout the United States.

    Quantity

    62 systems