BEUDAMED
    FDA Enforcement Class II Ongoing

    ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600

    Recall: Z-2359-2023 · Reported August 16, 2023

    Enforcement

    Recall Number
    Z-2359-2023
    Event ID
    92653
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 16, 2023
    Initiation Date
    June 19, 2023
    Classification Date
    August 8, 2023
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600

    Reason

    Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

    Code Info

    UDI-DI: 4056869063317 Serial Numbers: 180550 180517 180518 180546 180547 180560 180534 180556 180537 180545 180533 180566 180536 180563

    Distribution

    Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Latvia, Luxembourg, Macedonia, Mexico, Monaco, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    14 units