BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    Recall: Z-0289-2022 · Reported December 1, 2021

    Enforcement

    Recall Number
    Z-0289-2022
    Event ID
    88888
    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
    December 1, 2021
    Initiation Date
    August 30, 2021
    Classification Date
    November 24, 2021
    Termination Date
    January 16, 2024
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    Reason

    software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

    Code Info

    Serial Numbers: Serial Number 122022 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 122008 122036 122029 122044 122172 122074 122075 122049 122141 122167 122156 122081 122126 122129 122090 122130 122089 122085 122037 122009 122163 122064 122038 122161 122168 122158 122144 122063 122086 122035 122041 122114 122107 122101 122108 122109 122162 122125 122011 122052 122034 122057 122145 122147 122106 122061 122051 122166 122170 122092 122004

    Distribution

    US Nationwide distribution.

    Quantity

    64 units