Device recall
Z-0427-2014: Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio…
FDA device recall · Class II · Cutera, Inc.
Key facts
| Recall number (Z-number) | Z-0427-2014 |
|---|---|
| Recall event | 66674 |
| Product | Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared… |
| Product code | OPT |
| Recalling firm | Cutera, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 9, 2013 |
| 510(k) numbers | K122389 |
| FEI number | 3002900199 |
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