Z-0345-04

Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The Prostatron is a computer-controlled...

Name: Z-0345-04 Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The Prostatron is a computer-controlled...
Creator: Urologix, Inc.
Published: 2003-12-10
License: https://open.fda.gov/license/

Urologix, LLC / initiated 2003-12-10 / Terminated

FDA source

Urologix, Inc. began a recall of Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The Prostatron is a computer-controlled device designed to deliver microwave energy to... on 2003-12-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0345-04
Status: Terminated
Initiated: 2003-12-10
Posted: 2004-07-20
Terminated: 2005-11-15
Recalling firm: Urologix, LLC
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.
Product code: MEQ System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
Reason for recall: 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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 146 units
Distribution: The product was shipped to consignees located nationwide in the United States and to foreign consignees in Australia, France and Japan.
Product codes and lots: Serial numbers PP80023 through PP80040 and PP037 through PP180

Product code MEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)