BEUDAMED
    FDA Recall Terminated

    syngo.via RT Image Suite with software versions syngo.via VB30 or VB40

    Recall: Z-2688-2020 · Initiated June 24, 2020

    Recall

    Recall Number
    Z-2688-2020
    Event Number
    86000
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 24, 2020
    Terminated
    April 5, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355

    Description

    syngo.via RT Image Suite with software versions syngo.via VB30 or VB40

    Reason

    If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthetic CT , the software does not recognize the adapted acquisition plane. This may result in images with wrong geometry. When this distortion remains unnoticed and the images are subsequently exported to a treatment planning system (TPS), an incorrect calculated radiation treatment plan cannot be excluded. The occurence of this issue is very unlikely and has never been reported so far.

    Action

    Siemens Healthcare Diagnostics sent a letter notification to customers dated June 23, 2020. The described issue will be solved with a service pack for software versions syngo.via VB30 and syngo.via VB40. Depending on your current software version, the service pack VB30A_HF08 will be installed with update SY039/20/S or the service pack VB40B_HF01 with update SY040/20/S as soon as it is available.

    Distribution

    US Nationwide distribution including in the states of AZ, MA, WI, FL, PA. TX, MD, LA, TX, MN, MI, NY, SC, OH, GA, CA, IL, MO, CA, TX.

    Quantity

    21 units