BEUDAMED
    FDA Enforcement Class II Terminated

    AXIOM Artis dTC, Model Number 7413078

    Recall: Z-2021-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2021-2019
    Event ID
    83203
    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 31, 2019
    Initiation Date
    June 12, 2019
    Classification Date
    July 22, 2019
    Termination Date
    September 18, 2020
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    AXIOM Artis dTC, Model Number 7413078

    Reason

    A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

    Code Info

    Serial Numbers: 46022 46023 46154 46107 46263 46091 46203 46100 46025 46034 46042 46063 46036 46245 46062 46198 46169 46272 46117 46051 46137 46157 46215 46216 46219 46220 46221 46108 46040 46124 46126 46225 46226 46120 46152 46223 46130 46241 46213 46128 46205 46231 46098 46133 46271 46060 46085 46201 46182 46122 46065 46143 46144 46186 46097 46111 46067 46138 46269 46054 46125 46194 46190 46168 46180 46044 46127 46204 46112 46115 46118 46150 46164 46103 46113 46270 46178 46047 46106 46156 46202 46167 46163 46045 46158 46210 46179 46256 46192 46176 46170 46171 46174 46101 46139 46061 46035 46239

    Distribution

    US Nationwide Distribution

    Quantity

    98