BEUDAMED
    FDA Enforcement Class II Terminated

    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

    Recall: Z-0997-2022 · Reported May 4, 2022

    Enforcement

    Recall Number
    Z-0997-2022
    Event ID
    89915
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 4, 2022
    Initiation Date
    March 7, 2022
    Classification Date
    April 22, 2022
    Termination Date
    December 19, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

    Reason

    Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

    Code Info

    Partial UDI: 04056869249247, Serial Numbers 130088, 130081, 130075, 130090, 130087, 130074, 130069, 130091, 130092, 130086, 130079, 130089, 130077, 130071

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom.

    Quantity

    14 (US)