BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system

    Recall: Z-1845-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1845-2014
    Event ID
    66315
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    August 28, 2013
    Classification Date
    June 20, 2014
    Termination Date
    February 24, 2015
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: 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 the image appearing very dark, which may prompt unnecessary repetition of the examination.

    Code Info

    Model numbers 10094910, 10281013, and 10281163 with software version VB10G.

    Distribution

    USA Nationwide Distribution in the states of OH, NJ, MA, CO, NY, CA, MD, OR, KY, PA, IL, VA, TX, MN, KS, GA, and WY.

    Quantity

    76