Drug recall
Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED…
FDA recall event 70810 · Class II · Natus Medical Incorporated
Key facts
| Event ID | 70810 |
|---|---|
| Recall numbers | Z-1412-2015 |
| Recalling firm | Natus Medical Incorporated |
| Product type | Devices |
| Products | Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve… |
| Initiation date | Mar 16, 2015 |
| Report date | Apr 22, 2015 |
| Termination date | Dec 20, 2016 |
| City | Seattle |
| State | WA |
| Country | United States |
| FEI number | 3018859 |
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: