BEUDAMED
    FDA Recall Terminated

    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

    Recall: Z-2257-2020 · Initiated April 23, 2020

    Recall

    Recall Number
    Z-2257-2020
    Event Number
    85615
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 23, 2020
    Terminated
    October 26, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355

    Description

    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

    Reason

    Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient

    Action

    Siemens issued Urgent Medical Device Correction (AX035/20/S) dated 4/23/20. The letter states reason for recall health risk and action to take: We urgently recommend not to use Quantification Application (QVA/QCA) on DSA images until the software problem has been resolved. If Quantification Application has already been used on DSA images in the past, please verify the results and diagnostic evaluation if applicable. Siemens will correct the error with a software patch via Update Instruction AX034/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.

    Distribution

    AZ, IL, UT, WI

    Quantity

    5 US