Events

Recall of Device Recall Urologix, Inc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Urologix, 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
    27983
  • Event Risk Class
    Class 2
  • Event Number
    Z-0345-04
  • Event Initiated Date
    2003-12-10
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30843
  • 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, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy - Product Code MEQ
  • Reason
    During treatments, using the prostatron units, the devices' temperature sensing system may change the rectal temperature reading by up to 2 degrees celsius and may briefly delay updates to the rectal temperature reading.
  • Action
    A letter about the problem, actions to take to avoid the problem, and the proposed software correction was sent to consignees on December 10, 2003. A software upgrade will be performed on all units in March 2004.

Device

Device Recall Urologix, Inc.
  • Model / Serial
    Serial numbers PP80023 through PP80040 and PP037 through PP180
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    The product was shipped to consignees located nationwide in the United States and to foreign consignees in Australia, France and Japan.
  • Product Description
    Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperplasia). The Prostatron utilizes a transurethral microwave antenna, with simultaneous urethral cooling, to heat the prostate. This heating process is regulated through feedback from a series of temperature sensors.
  • Manufacturer
    Urologix, Inc.

Manufacturer

Urologix, Inc.
  • Manufacturer Address
    Urologix, Inc., 14405 21st Ave N, Minneapolis MN 55447-4685
  • Source
    USFDA