BEUDAMED
    FDA Enforcement Class II Terminated

    Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 10094135 Product Usage: 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-2302-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2302-2020
    Event ID
    85647
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2020
    Initiation Date
    April 30, 2020
    Classification Date
    June 9, 2020
    Termination Date
    September 11, 2020
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355, United States

    Description

    Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 10094135 Product Usage: 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

    Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated and performed on an alternative x-ray system

    Code Info

    Serial Numbers: Serial 125253 103340 121526 121521 103335 109621 138311 148418 147237 109620 136555 121520 121525 121518 125254

    Distribution

    US Nationwide distribution.

    Quantity

    15 US