FDA Device recall Z-2001-2016

Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066

FDA Device
Class II
terminated
Published 2016-06-22

On 2016-06-22 the FDA classified a Class II recall of Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066 by Natus Medical, citing the firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2001-2016
Classification	Class II
Status	terminated
Initiated	2016-04-11
Published	2016-06-22
Last updated	2026-09-13 11:54 UTC
Company	Natus Medical
Distribution	US

Product

Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia

Reason

The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.

Identifiers

code_info	Serial numbers of units distributed in American Samoa, Guam, Puerto Rico and in the US: .22938, .23282, .23283, .232… Serial numbers of units distributed in American Samoa, Guam, Puerto Rico and in the US: .22938, .23282, .23283, .23289, .23291, .23302, .23307, .23471, .23473, .23478, .23479, .23480, .23481, .23483, .23538, .23697, .23708, .23887, .23888, .23895, .23916, .23939, .23968, .23969, .23972, .23983, .23993, .23994, .23998, 040756-1, 040756-2, 1, 10090, 10507, 10559, 10592, 10595, 10597, 10598, 10613, 10633, 10634, 10635, 10636, 10637, 10638, 10639, 10640, 10642, 10643, 10645, 10646, 10659, 10660, 10661, 10662, 10663, 10666, 10667, 10668, 10671, 10678, 10679, 10680, 10681, 10682, 10683, 10684, 10684, 10685, 10686, 10687, 10688, 10701, 10702, 10703, 10704, 10705, 10706, 10707, 10708, 10709, 10710, 10711, 10712, 10713, 10714, 10715, 10716, 10717, 10718, 10719, 10725, 10727, 10728, 10730, 10731, 10732, 10734, 10739, 10740, 10743, 10744, 10759, 10760, 10761, 10762, 10763, 10764, 10765, 10766, 10767, 10768, 10771, 10773, 10774, 10775, 10776, 10777, 10778, 10779, 10781, 10782, 10783, 10784, 107

code_info

Serial numbers of units distributed in American Samoa, Guam, Puerto Rico and in the US: .22938, .23282, .23283, .232…

Serial numbers of units distributed in American Samoa, Guam, Puerto Rico and in the US: .22938, .23282, .23283, .23289, .23291, .23302, .23307, .23471, .23473, .23478, .23479, .23480, .23481, .23483, .23538, .23697, .23708, .23887, .23888, .23895, .23916, .23939, .23968, .23969, .23972, .23983, .23993, .23994, .23998, 040756-1, 040756-2, 1, 10090, 10507, 10559, 10592, 10595, 10597, 10598, 10613, 10633, 10634, 10635, 10636, 10637, 10638, 10639, 10640, 10642, 10643, 10645, 10646, 10659, 10660, 10661, 10662, 10663, 10666, 10667, 10668, 10671, 10678, 10679, 10680, 10681, 10682, 10683, 10684, 10684, 10685, 10686, 10687, 10688, 10701, 10702, 10703, 10704, 10705, 10706, 10707, 10708, 10709, 10710, 10711, 10712, 10713, 10714, 10715, 10716, 10717, 10718, 10719, 10725, 10727, 10728, 10730, 10731, 10732, 10734, 10739, 10740, 10743, 10744, 10759, 10760, 10761, 10762, 10763, 10764, 10765, 10766, 10767, 10768, 10771, 10773, 10774, 10775, 10776, 10777, 10778, 10779, 10781, 10782, 10783, 10784, 107

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2001-2016%22

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