Class II — Natus Medical Incorporated
| Recalling firm | Natus Medical Incorporated |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box. |
| Product | 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 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE … |
| Quantity | 2611 units (1911 units in the US and 700 units outside the US) |
| Distribution | distributed worldwide |
| Initiated | 2015-03-16 |
| Classified | 2015-04-10 |
| Terminated | 2016-12-20 |
| Recall number | Z-1412-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Natus Medical Incorporated (Z-1412-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70810/
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