Inc., Class II Urologix

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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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