FDA Device recall Z-1412-2015
Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Larg…
- FDA Device
- Class II
- terminated
- Published 2015-04-22
On 2015-04-22 the FDA classified a Class II recall of Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Larg… by Natus Medical, citing 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. Thes….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1412-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-16 |
| Published | 2015-04-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Natus Medical |
| Distribution | n/a |
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 blanket LED Phototherapy Systems with Large blanket/pad AUS 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
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.
Identifiers
| code_info | None |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Natus Medical
- External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
FDA Device · Class II · 2024-01-10 · Natus Medical - EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
FDA Device · Class II · 2024-01-10 · Natus Medical - The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to crea…
FDA Device · Class II · 2022-12-28 · Natus Medical - The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy an…
FDA Device · Class II · 2017-07-19 · Natus Medical - Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008
FDA Device · Class II · 2017-05-10 · Natus Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1412-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.