Device recall
Z-0234-2016: miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry…
FDA device recall · Class II · Miramar Labs, Inc.
Key facts
| Recall number (Z-number) | Z-0234-2016 |
|---|---|
| Recall event | 72386 |
| Product | miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of… |
| Product code | OUB |
| Recalling firm | Miramar Labs, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 23, 2015 |
| 510(k) numbers | K103014, K131162, K150419 |
| 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