BEUDAMED
    FDA Enforcement Class II Terminated

    Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.

    Recall: Z-2108-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2108-2013
    Event ID
    65793
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    April 26, 2013
    Classification Date
    August 28, 2013
    Termination Date
    November 6, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355, United States

    Description

    Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.

    Reason

    The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.

    Code Info

    Multiple Model numbers: 10281163, 10281013, 10280959, 10272410, 10094200, 10094142, 10094141, 10094139, 10094137, 10094135, 10093961, 10093902, 8890415, 8890407, 8627718, 8395431, 8395415, 8395399, 8395381, 7728392, 7555373, 755365, 7555357, 7412807, 7151066, 7008605, 5904441, 5904433, 5895003, 475525, 475517, 475509.

    Distribution

    US Distribution including the states of PA, NJ, DC, VA, MD and DE.

    Quantity

    178