BEUDAMED
    FDA Recall Terminated

    Syngo.plaza, Picture Archiving and Communications System (PACS) 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-1533-2017 · Initiated February 20, 2017

    Recall

    Recall Number
    Z-1533-2017
    Event Number
    76639
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 20, 2017
    Posted
    March 10, 2017
    Terminated
    August 7, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Syngo.plaza, Picture Archiving and Communications System (PACS) 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

    Software updates

    Action

    Siemens mailed a notification letter dated February 21, 2017 to affected customers to inform them of the software updates that were now available to address several issues. Customers were advised to follow the instructions in the notice and where necessary promptly notify and instruct all their staff at their organization who have to be aware of the problem. Customers were also instructed to forward the information to new owners where possible. For questions regarding this recall call 610-219-4834.

    Distribution

    Nationwide Distribution to MO,TX, FL, MA, WI, PA, IN, and CA

    Quantity

    13 systems