BEUDAMED
    FDA Recall Terminated

    AXIOM Artis System dFC using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.

    Recall: Z-0312-2009 · Initiated August 25, 2008

    Recall

    Recall Number
    Z-0312-2009
    Event Number
    49569
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 25, 2008
    Posted
    December 9, 2008
    Terminated
    January 26, 2010
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    AXIOM Artis System dFC using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.

    Reason

    System may switch to emergency fluoroscopy mode.

    Action

    A Customer Safety Advisory Letter dated 8/20/08 was issued with Update Instructions AX045/08/S. The letter informed the customer of the potential issue and provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the issue.

    Distribution

    Nationwide Distribution including states of AR, CA, CO, FL, IA, IL, IN, KS, KY, MI, NY, TX, VA, and WY.

    Quantity

    4 units