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.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Urologix, Inc.
- Recall Initiated
- December 10, 2003
- Posted
- July 20, 2004
- Terminated
- November 15, 2005
- Recall Number
- Z-0345-04
- Quantity
- 146 units
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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.
Distribution
The product was shipped to consignees located nationwide in the United States and to foreign consignees in Australia, France and Japan.
Lot / Code Info
Serial numbers PP80023 through PP80040 and PP037 through PP180
Root Cause
Other
Action Taken
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.
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