Events

Recall of Siemens RAD Flouro Uro

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66314
  • Event Risk Class
    Class 2
  • Event Number
    Z-0140-2014
  • Event Initiated Date
    2013-09-03
  • Event Date Posted
    2013-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122033
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 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.

Device

Siemens RAD Flouro Uro
  • Model / Serial
    Model numbers 10094910 and 10094200 with software version VD10A/G.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada.
  • Product Description
    Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G || Image intensified Fluoroscopic X-ray system
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA