Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The Prostatron is a computer-controlled device des
FDA device recall Z-0345-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Urologix, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEQ
- Quantity affected
- 146 units
- Distribution
- The product was shipped to consignees located nationwide in the United States and to foreign consignees in Australia, France and Japan.
- Date initiated
- 2003-12-10
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-15
- Location
- Minneapolis, MN
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