BEUDAMED
    FDA Enforcement Class II Terminated

    Syngo.plaza; picture archiving and communications system Product Usage: 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 workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

    Recall: Z-2719-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2719-2015
    Event ID
    71978
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    July 6, 2015
    Classification Date
    September 2, 2015
    Termination Date
    January 6, 2017
    Address
    40 Liberty Blvd, Mail Code: 65-1A, Malvern, PA, 19355-1418, United States

    Description

    Syngo.plaza; picture archiving and communications system Product Usage: 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 workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

    Reason

    Potential issue leading to data loss and patient data mix-up

    Code Info

    Model Number of device 10592457 with serial numbers: Serial 100544 100499 100600 100571 100263 200308 200309 200310 200311 200312 200313 200314 200315 200316 200317 200318 200319 200320 200321 200322 200323 200324 100146 200277 100177 100138 100174 100491 100492 100596 100198 100181 200251 200252 100301 100302 100539

    Distribution

    US Nationwide Distribution - in the states of CA, OR, FL, MO, NY, WA, MD, MA, NY, WI, KS, MN and PA.

    Quantity

    37