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U.S. Department of Health and Human Services

Class 2 Device Recall Urologix, Inc.

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  Class 2 Device Recall Urologix, Inc. see related information
Date Initiated by Firm December 10, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 15, 2005
Recall Number Z-0345-04
Recall Event ID 27983
PMA Number P950014 
Product Classification System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy - Product Code MEQ
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.
Code Information Serial numbers PP80023 through PP80040 and PP037 through PP180
Recalling Firm/
Manufacturer		 Urologix, Inc.
14405 21st Ave N
Minneapolis MN 55447-4685
For Additional Information Contact Tod Paulson
763-475-4100
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MEQ and Original Applicant = Urologix, Inc.
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