Device recall
Z-1094-2014: NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency…
FDA device recall · Class II · Hologic, Inc
Key facts
| Recall number (Z-number) | Z-1094-2014 |
|---|---|
| Recall event | 67375 |
| Product | NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with… |
| Product code | MNB |
| Recalling firm | Hologic, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2014 |
| PMA numbers | P010013 |
| FEI number | 1000120743 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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