Company: Urologix, Inc.,
Date of Enforcement Report: 1/21/04
Class: II
PRODUCT
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.
REASON
During treatment the Temperature Sensing System may change the rectal temperature reading by up to 2 degrees celcius and may briefly delay updates to the rectal temperature reading.
CODE
Serial numbers PP80023 through PP80040 and PP037 through PP180.
RECALLING FIRM/MANUFACTURER
Urologix, Inc., Minneapolis, MN, by letter on December 10, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
146.
DISTRIBUTION
Nationwide, Australia, France, and Japan.
