BEUDAMED
    FDA Recall Terminated

    Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

    Recall: Z-2793-2016 · Initiated August 2, 2016

    Recall

    Recall Number
    Z-2793-2016
    Event Number
    75125
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLG
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    August 2, 2016
    Posted
    September 14, 2016
    Terminated
    March 20, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

    Reason

    Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.

    Action

    Siemens mailed to customers on August 04, 2016 a Customer Advisory Notice that provided interpretations about the meaning of measurement values like area, distance and perimeter shown as "o.p." by the syngo.plaza.

    Distribution

    Nationwide Distribution

    Quantity

    101 Systems