Urologix, Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Urologix, Inc.
Lot Codes / Batch Numbers
Serial numbers PP80023 through PP80040 and PP037 through PP180
Products Sold
Serial numbers PP80023 through PP80040 and PP037 through PP180
Urologix, Inc. is recalling Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The Prostatron is a computer- due to During treatments, using the Prostatron units, the devices' Temperature Sensing System may change the rectal temperature reading by up to 2 degrees Ce. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026