Events

Recall of Device Recall Siemens RAD Fluoro 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
    66315
  • Event Risk Class
    Class 2
  • Event Number
    Z-1845-2014
  • Event Initiated Date
    2013-08-28
  • Event Date Posted
    2014-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122034
  • 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, stationary - Product Code KPR
  • 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.
  • Action
    Siemens sent a notification letter, dated August 28, 2013, to Affected customers. The letter identified the affected product, problem and actions to be taken. The letter provided work-around instructions and announced that a field modification was prepared to resolve the issue.

Device

Device Recall Siemens RAD Fluoro Uro
  • Model / Serial
    Model numbers 10094910, 10281013, and 10281163 with software version VB10G.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. || Product Usage: 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