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Terminated

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.

FDA Recall Z-0345-04 · Posted 2004-07-20

Recalling FirmUrologix, Inc.
Recall StatusTerminated
Product CodeMEQ
Date Initiated2003-12-10
Date Terminated2005-11-15
Product Quantity146 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

The product was shipped to consignees located nationwide in the United States and to foreign consignees in Australia, France and Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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