BEUDAMED
    FDA Recall Terminated

    Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807.

    Recall: Z-0120-2009 · Initiated September 2, 2008

    Recall

    Recall Number
    Z-0120-2009
    Event Number
    49584
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 2, 2008
    Posted
    November 25, 2008
    Terminated
    October 5, 2009
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807.

    Reason

    Incorrect contour finding: Image may be calibrated to the wrong size catheter.

    Action

    Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.

    Distribution

    Nationwide.

    Quantity

    145 units