Device Recall Urologix, Inc.

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers PP80023 through PP80040 and PP037 through PP180
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    The product was shipped to consignees located nationwide in the United States and to foreign consignees in Australia, France and Japan.
  • 제품 설명
    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

제조사

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