Device recall
Z-2591-2011: MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP)…
FDA device recall · Class II · Miramar Labs, Inc.
Key facts
| Recall number (Z-number) | Z-2591-2011 |
|---|---|
| Recall event | 58853 |
| Product | MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraDry biotip and the miraDry Treatment Template system. Miramar Labs, Inc. 445 Indio Way Sunnyvale, CA 94085 Intended use: Treatment of primary axillary hyperhidrosis. |
| Product code | OUB |
| Recalling firm | Miramar Labs, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 17, 2011 |
| 510(k) numbers | K103014 |
| FEI number | 3008082710 |
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