Events

Recall of Device Recall Siemens Uroskop

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Systems 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
    25329
  • Event Risk Class
    Class 2
  • Event Number
    Z-0493-03
  • Event Initiated Date
    2002-11-27
  • Event Date Posted
    2003-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25604
  • 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
    Table, Radiographic, Tilting - Product Code IXR
  • Reason
    There is unintended system movement or unwanted automatic movement of the tabletop.
  • Action
    Siemens personal will install Host Software VA00F and Generator Host Software VE00D on affected Uroskop units. Update instructions were sent to users November 27,2002 and December 7, 2002.

Device

Device Recall Siemens Uroskop
  • Model / Serial
    Uroskop D1 -- Model #9785023 Uroskop D2/D3 -- Model #9785015
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 6 hospitals nationwide and 5 government hospitals. Internationally, the tables were distributed to Germany, Netherlands, Italy , Luxembourg, Sweden, Austria, Switzerland, Slovakia, Hungary, Ukraine, Russia, Turkmenistan, South Africa, Canada, Malaysia, Japan, and Taiwan.
  • Product Description
    Uroskop D1/D2/D3 - Table, Radiographic, Stationary Top.
  • Manufacturer
    Siemens Medical Systems Inc

Manufacturer

Siemens Medical Systems Inc
  • Manufacturer Address
    Siemens Medical Systems Inc, 186 Wood Ave So, Iselin NJ 08830
  • Source
    USFDA