Device recall
Z-0887-2009: Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant…
FDA device recall · Class II · Regenesis Biomedical Inc
Key facts
| Recall number (Z-number) | Z-0887-2009 |
|---|---|
| Recall event | 50230 |
| Product | Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of… |
| Product code | ILX |
| Recalling firm | Regenesis Biomedical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2009 |
| 510(k) numbers | K972093 |
| FEI number | 3003070149 |
At a glance
- 1–9 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