FDA Device recall Z-0770-2017
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy
- FDA Device
- Class II
- terminated
- Published 2016-12-21
On 2016-12-21 the FDA classified a Class II recall of Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy by Natus Medical, citing neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0770-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-28 |
| Published | 2016-12-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Natus Medical |
| Distribution | US |
Product
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 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 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
Reason
neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box.
Identifiers
| code_info | ************SERIAL NUMBERS OF UNITS DISTRIBUTED TO US GOVERMENT ACCOUNTS 000089, 000104, 000128, 001342, 001364, 001…************SERIAL NUMBERS OF UNITS DISTRIBUTED TO US GOVERMENT ACCOUNTS 000089, 000104, 000128, 001342, 001364, 001367, 001371, 001372, 001373, 001374, 001375, 001376, 001377, 001391, 001392, 001393, 001394, 001441, 001442, 001455, 001456, 001463, 001495, 001496, 001497, 001878, 001893, 001912, 001915, 001992, 001993, 002040, 002041, 002165, 002166, 002167, 002168, 002289, 002290, 002291, 002292, 002320, 002462, 002463, 002762, 002763, 002766, 002860, 002870, 002873, 002888, 003594, 003595, 003600, 003604, 003632, 003633, and 003893. ***********SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US ..000284, ..000287, ..000297, ..000299, ..000310, ..000324, ..000328, ..000365, .000301, .000313, .000321, .000322, .000323, .000352, .000415, .000419, .000420, .000426, .000427, .000435, .000445, .000449, .000467, .000483, .000508, .000518, .000523, .000531, .000541, .000581, .000651, .000670, .000695, .000696, .000697, .000698, 000030, 000031, 000032, 000033, 000035, 000036, 000039, 00004 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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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-0770-2017%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.