Drug recall
NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001…
FDA recall event 67375 · Class II · Hologic, Inc
Key facts
| Event ID | 67375 |
|---|---|
| Recall numbers | Z-1094-2014 |
| Recalling firm | Hologic, Inc |
| Product type | Devices |
| Products | NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, |
| Initiation date | Jan 24, 2014 |
| Report date | Mar 5, 2014 |
| Termination date | Jul 17, 2014 |
| City | Marlborough |
| State | MA |
| Country | United States |
| FEI number | 1000120743 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: