Z-1412-2015Class II

Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED...

Name: Z-1412-2015 Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED...
Creator: Natus Medical Incorporated
Published: 2015-03-16
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2015-03-16 / Terminated

FDA source

Natus Medical Incorporated began a recall of Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254... on 2015-03-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1412-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-16
Posted: 2015-04-10
Terminated: 2016-12-20
Recalling firm: Natus Medical Incorporated
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
Product code: LBI Unit, Neonatal Phototherapy
Reason for recall: 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.
FDA root cause: Other
Action: Natus sent the PRODUCT RELIABILITY ALERT neoBLUE blanket system performance along with an attached Technical Bulletin, Instructions for Use, and Service Manual to consignees via email during the week of March 16, 2015. Natus emailed the Distribution Partner (DP) letter to all Natus International Distribution Partners, requiring that they notify their customers (at Biomedical Department and Neonatal Intensive Care Unit) with copies of the Field Safety Notice, customer letter, the Technical Bulletin, Instructions for Use, and Service Manual. The technical bulletin asks the customer to visually and tactilely inspect the fiber optic cable connector before use, and to call Natus if they notice a failing pad. This procedure will prevent the complete degradation and therapy will not be compromised. U.S. customers should contact Natus Technical Service at 888-496-2887 with any questions regarding this notification. International customers should contact their local distributors or contact Natus Technical Service at (888) 496-2887 or [email protected].
Quantity in commerce: 2611 units (1911 units in the US and 700 units outside the US)
Distribution: distributed worldwide
Product codes and lots: None

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1412-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1412-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-22	2015-04-10

Product code LBI

K103589Class IINeoblue Blanket LED Phototherapy SystemNatus Medical Incorporated / cleared 2011-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)