BEUDAMED
    FDA Recall 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 · Initiated September 3, 2013

    Recall

    Recall Number
    Z-0140-2014
    Event Number
    66314
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 3, 2013
    Posted
    November 27, 2013
    Terminated
    March 9, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    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.

    Action

    Siemens sent an Field Safety Notice dated September 3, 2013, to all affected customers.The letter identified the product the problem and the action to be taken by the customer. Action to be taken: 1. It is not possible for the user to prevent this malfunction. The exposure time with the use of automatic exposure control is limited to 500ms, which is the maximum duration of radiation in this mode. The exposure can be interrupted by the user at anytime by releasing the exposure button. 2. There are two possibilities to solve this issue: a.) Switch off the system if the message "wait for FLC" in status bar does not disappear approximately. 30s after the OGP selection. The system gets ready after switching the system on and reselecting the Torno OGP. b.) Press Shift+F10. The pop up message has to be confirmed and you have to wait approximately. 40s until! the "i" icon in the status bar stops blinking. After that a RAD OGP has to be selected and then the Torno OGP. Thereafter, the system gets ready. 3. It is not possible for the user to prevent this malfunction The Center for Devices and Radiological Health (CDRH) understands that your Corrective Action Plan (CAP) will involve 59 units and consist of the following elements: 1. You have notified affected customers with Field Safety Notice XP032/13/S. 2. You have prepared a field modification of the Luminos dRF and Uroskop Omnia systems with software version VD10A/G. 3. Distribution of this field modification will began in September 2013 as Update Instruction XP015/13/S at no cost to the user. For further Customer Support call (610) 219-6300.

    Distribution

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

    Quantity

    59