Device recall
Z-0345-04: Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The…
FDA device recall · Class II · Urologix, Inc.
Key facts
| Recall number (Z-number) | Z-0345-04 |
|---|---|
| Recall event | 27983 |
| 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… |
| Product code | MEQ |
| Recalling firm | Urologix, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 15, 2005 |
| PMA numbers | P950014 |
| FEI number | 3000718675 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database