BEUDAMED
    FDA Recall Terminated

    Syngo.plaza: 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-1027-2015 · Initiated January 13, 2015

    Recall

    Recall Number
    Z-1027-2015
    Event Number
    70318
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    January 13, 2015
    Posted
    January 28, 2015
    Terminated
    February 16, 2017
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    Syngo.plaza: 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

    In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.

    Action

    Siemens sent a Safety Advisory Notice dated January 13, 2015, to all affected customers. The Safety Notice identified the product, the problem, and the action to be taken. Siemens recommended checking patient data in the event of a system crash and advised customers that a software update is planned for mid-2015 that will resolve the issue. For questions regarding this recall call 610-219-6300.

    Distribution

    Nationwide Distribution

    Quantity

    50