BEUDAMED
    FDA Enforcement Class II Terminated

    Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

    Recall: Z-0481-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0481-2016
    Event ID
    72742
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2015
    Initiation Date
    October 30, 2015
    Classification Date
    December 24, 2015
    Termination Date
    March 28, 2017
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

    Reason

    Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening.

    Code Info

    Model numbers 10094135, 10094137, 10094141, 10848280, 10848281, 10848282, 10848355. Serial Numbers 123026, 147909, 123031, 103030, 147912, 147910, 147921, 147919, 131005, 121096, 125004, 137551, 121088, 109104, 109105, 109107, and 121085.

    Distribution

    US Distribution to the states of : IL, WI, MA, FL, AL, TN, ND, OH, TX, CA, NJ and MI.

    Quantity

    17