BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2108-2013 · Initiated April 26, 2013

    Recall

    Recall Number
    Z-2108-2013
    Event Number
    65793
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 26, 2013
    Posted
    August 28, 2013
    Terminated
    November 6, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    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.

    Action

    Siemens sent Update Instructions dated December 2012, to all affected customers. This update was initiated on behalf of the US service organization to re-check all systems installed by MEC Group. A call center representative or designated engineer called each site on April 26, 2013, and described the work being done, amount of time needed and number of engineers that would be on site. At that time the call center or engineer scheduled the update with the customer. For further questions please call (610) 219-6300.

    Distribution

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

    Quantity

    178