Device Recall Urologix, Inc.

  • Modèle / numéro de série
    Serial numbers PP80023 through PP80040 and PP037 through PP180
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped to consignees located nationwide in the United States and to foreign consignees in Australia, France and Japan.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Urologix, Inc., 14405 21st Ave N, Minneapolis MN 55447-4685
  • Source
    USFDA