BEUDAMED
    FDA Enforcement Class II Ongoing

    Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

    Recall: Z-0656-2021 · Reported January 20, 2021

    Enforcement

    Recall Number
    Z-0656-2021
    Event ID
    87026
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    January 20, 2021
    Initiation Date
    November 30, 2020
    Classification Date
    January 11, 2021
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355, United States

    Description

    Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

    Reason

    When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.

    Code Info

    Model number: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Pheno- 10849000 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355

    Distribution

    Worldwide-US Nationwide

    Quantity

    5602