BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2688-2020 · Reported July 29, 2020

    Enforcement

    Recall Number
    Z-2688-2020
    Event ID
    86000
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2020
    Initiation Date
    June 24, 2020
    Classification Date
    July 22, 2020
    Termination Date
    April 5, 2023
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355, United States

    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.

    Code Info

    syngo.via VB30 or VB40: All Lots Model #: 10496180

    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