BEUDAMED
    FDA Enforcement Class II Ongoing

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    Recall: Z-2445-2021 · Reported September 22, 2021

    Enforcement

    Recall Number
    Z-2445-2021
    Event ID
    88588
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 22, 2021
    Initiation Date
    August 16, 2021
    Classification Date
    September 10, 2021
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    Reason

    Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

    Code Info

    Serial Numbers: 100713 223736 222946 223440 223032 223347 223084 223811 130643 223004 451078 101724 132011 131247 451036 132231 451032 222835 130848 500010 101773 132729 130874 133176 100421 100419 100420 100643 100642 100811 100814 100644 102369 100812 100641 100418 100813 100645 131284 130712 223734 102305 132893 223310 222411 223258 223334 223090 132781 131867 222563 222417 222491 131503 130125 451070 222224 132108 500013 132061 131169 451023 451017 451077 132701 102113 451094 130628 500007 131213 131360 500020 500028 451079 132205 451031 451001 222914 130331 451034 133191 102108 132136 131325 222686 223207 130734 102021 131578 500005 451071 222521 132904 102031 222539 222860 451039 130335 222862 222638 100677 222729 131336 223188 130452 223220 131801 131589 222719 132102 130140 223844 500004 451074 451030 133198 222601 133261 132595 130751 223150 131966 223424 223259 223058 131012 ***Updated 12/9/21*** 223021 ***Updated 1/31/22: Serial number 222475 133503

    Distribution

    US Nationwide distribution.

    Quantity

    126 units