BEUDAMED
    FDA Enforcement Class II Ongoing

    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-2241-2024 · Reported July 10, 2024

    Enforcement

    Recall Number
    Z-2241-2024
    Event ID
    94892
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens AG/Siemens Healthcare GmbH
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    July 10, 2024
    Initiation Date
    June 26, 2024
    Classification Date
    July 2, 2024
    Address
    Rittigfeld 1, N/A, Forchheim, N/A, N/A, Germany

    Description

    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

    A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

    Code Info

    ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325

    Distribution

    Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.

    Quantity

    201 units in total