BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system

    Recall: Z-0140-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0140-2014
    Event ID
    66314
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    September 3, 2013
    Classification Date
    November 27, 2013
    Termination Date
    March 9, 2015
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system

    Reason

    When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination.

    Code Info

    Model numbers 10094910 and 10094200 with software version VD10A/G.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada.

    Quantity

    59