BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0345-04 · Initiated December 10, 2003

    Recall

    Recall Number
    Z-0345-04
    Event Number
    27983
    Firm
    Urologix, Inc.
    FEI Number
    3000718675
    Product Code
    MEQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 10, 2003
    Posted
    July 20, 2004
    Terminated
    November 15, 2005
    Address
    14405 21st Ave N, Minneapolis, MN, 55447-4685

    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.

    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.

    Distribution

    The product was shipped to consignees located nationwide in the United States and to foreign consignees in Australia, France and Japan.

    Quantity

    146 units