BEUDAMED
    FDA Recall Terminated

    Syngo Dynamics; Kinetdx Picture Archiving and Communications System

    Recall: Z-1601-2016 · Initiated April 14, 2016

    Recall

    Recall Number
    Z-1601-2016
    Event Number
    73907
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 14, 2016
    Posted
    May 4, 2016
    Terminated
    March 20, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Syngo Dynamics; Kinetdx Picture Archiving and Communications System

    Reason

    Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.

    Action

    Siemens mailed out a "Customer Advisory Notice" #SY009/16/P to customers informing them of the issue and what to do if it was to occur. Siemens informed customers that they are working on the "carry forward" feature enhancement and is planning to release a software update VA10B_HF06 and they should follow the instructions in the advisory notice until the update is performed.

    Distribution

    Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI

    Quantity

    84 units