BEUDAMED
    FDA Enforcement Class II Terminated

    AXIOM Artis dBC, Model Number 7728392

    Recall: Z-2027-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2027-2019
    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 dBC, Model Number 7728392

    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: 44125 44151 44101 44246 44185 44262 44263 44199 44105 44084 44080 44072 44243 44198 44171 44275 44215 44255 44081 44242 44265 44189 44289 44145 44060 44144 44184 44286 44223 44068 44193 44244 44201 44251 44229 44304 44152 44136 44254 44277 44279 44268 44206 44278 44259 44260 44168 44267 44110 44218 44165 44271 44135

    Distribution

    US Nationwide Distribution

    Quantity

    53