FDA Device recall Z-0149-2016

Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066

FDA Device
Class II
terminated
Published 2015-10-28

On 2015-10-28 the FDA classified a Class II recall of Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066 by Natus Medical, citing the neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0149-2016
Classification	Class II
Status	terminated
Initiated	2015-08-05
Published	2015-10-28
Last updated	2026-09-13 11:53 UTC
Company	Natus Medical
Distribution	US

Product

Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103

Reason

The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.

Identifiers

code_info	SERIAL NUMBERS: 0.23998, 1, 13201, 18002, 18003, 18004, 18005, 18006, 18007, 18008, 18009, 18010, 18011, 18012, 1801… SERIAL NUMBERS: 0.23998, 1, 13201, 18002, 18003, 18004, 18005, 18006, 18007, 18008, 18009, 18010, 18011, 18012, 18013, 18015, 18016, 18017, 18018, 18019, 18020, 18021, 18022, 18023, 18040, 18041, 18042, 18043, 18044, 18045, 18046, 18047, 18048, 18049, 18050, 18051, 18052, 18053, 18054, 18055, 18056, 18057, 18058, 18059, 18060, 18061, 18062, 18063, 18064, 18065, 18066, 18067, 18068, 18069, 18070, 18071, 18072, 18073, 18074, 18075, 18076, 18077, 18078, 18086, 18087, 18088, 18089, 18090, 18091, 18092, 18118, 18119, 18120, 18121, 18122, 18133, 18134, 18302, 18303, 18304, 18305, 18306, 18307, 18308, 18309, 18310, 18311, 18312, 18313, 18314, 18315, 18316, 18317, 18318, 18319, 18320, 18328, 18329, 18330, 18331, 18332, 18333, 18334, 18335, 18336, 18337, 18338, 18339, 18340, 18341, 18342, 18343, 18344, 18345, 18346, 18347, 18348, 18349, 18350, 18351, 18352, 18353, 18355, 18356, 18357, 18358, 18359, 18360, 18361, 18362, 18363, 18364, 18365, 18366, 18367, 18368, 18369, 18370, 18371, 18372, 183

code_info

SERIAL NUMBERS: 0.23998, 1, 13201, 18002, 18003, 18004, 18005, 18006, 18007, 18008, 18009, 18010, 18011, 18012, 1801…

SERIAL NUMBERS: 0.23998, 1, 13201, 18002, 18003, 18004, 18005, 18006, 18007, 18008, 18009, 18010, 18011, 18012, 18013, 18015, 18016, 18017, 18018, 18019, 18020, 18021, 18022, 18023, 18040, 18041, 18042, 18043, 18044, 18045, 18046, 18047, 18048, 18049, 18050, 18051, 18052, 18053, 18054, 18055, 18056, 18057, 18058, 18059, 18060, 18061, 18062, 18063, 18064, 18065, 18066, 18067, 18068, 18069, 18070, 18071, 18072, 18073, 18074, 18075, 18076, 18077, 18078, 18086, 18087, 18088, 18089, 18090, 18091, 18092, 18118, 18119, 18120, 18121, 18122, 18133, 18134, 18302, 18303, 18304, 18305, 18306, 18307, 18308, 18309, 18310, 18311, 18312, 18313, 18314, 18315, 18316, 18317, 18318, 18319, 18320, 18328, 18329, 18330, 18331, 18332, 18333, 18334, 18335, 18336, 18337, 18338, 18339, 18340, 18341, 18342, 18343, 18344, 18345, 18346, 18347, 18348, 18349, 18350, 18351, 18352, 18353, 18355, 18356, 18357, 18358, 18359, 18360, 18361, 18362, 18363, 18364, 18365, 18366, 18367, 18368, 18369, 18370, 18371, 18372, 183

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0149-2016%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.