BEUDAMED
    FDA Enforcement Class II Terminated

    ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    Recall: Z-0400-2021 · Reported November 11, 2020

    Enforcement

    Recall Number
    Z-0400-2021
    Event ID
    86547
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2020
    Initiation Date
    September 18, 2020
    Classification Date
    November 4, 2020
    Termination Date
    July 23, 2021
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355, United States

    Description

    ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    Reason

    There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while the C-Arm or table is moving, there may be a shift between the image acquired at the start position and the image (i.e. DSA vessel map) taken at the reference position. This may lead to a DSA vessel map being overlaid to a subtracted fluoro image at a position that is not accurate.. However, if the displacement is slight or at an unfavorable plane, the user might rely on incorrect visualization of the catheter relative to the vessel map. This could imply danger to the patient.

    Code Info

    ARTIS Icono biplane - model # 11327600 ARTIS Icono Floor - model # 11327700 Serial numbers: 1) 170023 2) 170025 3) 170026 4) 170027 5) 180014 6) 180015 7) 180018 8) 180019 9) 180021 10) 180029 11) 180034 12) 180035 13) 180037 14) 180040 15) 180041 16) 180043 17) 180046 18) 180047 19) 180048 20) 180049 21) 180053 22) 180054 23) 180055 24) 180057 25) 180060 26) 180062 27) 180065 28) 180066 29) 180067 30) 180068 31) 180070 ***Updated 11/6/2020*** 180072

    Distribution

    US Nationwide distribution.

    Quantity

    100 distributed worldwide. 31 distributed nationwide in U.S.