Drug recall
Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers: 515-015400 for the 32 channel amplifier…
FDA recall event 64479 · Class II · Natus Neurology Incorporated
Key facts
| Event ID | 64479 |
|---|---|
| Recall numbers | Z-0946-2013 |
| Recalling firm | Natus Neurology Incorporated |
| Product type | Devices |
| Products | Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in… |
| Initiation date | Feb 27, 2013 |
| Report date | Mar 20, 2013 |
| Termination date | Apr 25, 2014 |
| City | Middleton |
| State | WI |
| Country | United States |
| FEI number | 3008289288 |
At a glance
- 1–9 Products in this recall
- None 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: