BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system

    Recall: Z-1750-2013 · Reported July 24, 2013

    Enforcement

    Recall Number
    Z-1750-2013
    Event ID
    65620
    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 24, 2013
    Initiation Date
    January 31, 2013
    Classification Date
    July 17, 2013
    Termination Date
    November 12, 2014
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system

    Reason

    During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.

    Code Info

    Material number 10094137 -- serial numbers 147515, 147500, 147528, 147514, 147516, 147526; material number 10094141 -- serial numbers 154408, 154406, 154453, 154423, 154430, 154425, 154429; material number 10280959 -- serial numbers 160813, 160823, 160812, 160800, 160431, 160814, 160807, 160817, 160816; material number 10094139 -- serial number 157907.

    Distribution

    United States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico.

    Quantity

    23