Z-0847-2015Class II

Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system...

Name: Z-0847-2015 Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system...
Creator: Natus Medical Incorporated
Published: 2014-11-19
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2014-11-19 / Terminated

FDA source

Natus Medical Incorporated began a recall of Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy on 2014-11-19. FDA classified it as Class II and gives the reason as "Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0847-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-19
Posted: 2014-12-22
Terminated: 2015-07-20
Recalling firm: Natus Medical Incorporated
Product: Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
Product code: LBI Unit, Neonatal Phototherapy
Reason for recall: Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.
FDA root cause: Other
Action: Natus Medical has begun mailing the Urgent Recall Notification/Field Safety Notice neoBLUE LED Board Replacements letter (DOC-012737B), dated November 5, 2014, to US consignees. Natus Medical also send the Product Advisory neoBLUE LED Board Replacements letter (DOC-0012738), dated October 30, 2014, to International Distribution Partners. Both US and International consignees also received the TECHNICAL BULLETIN LED Board Kit, neoBLUE 2 LED Phototherapy System, p/n: 001840, Treatment Intensity with revised LED board for neoBLUE 2 systems (p/n: 040904 & 040906) [DOC 008353]; and the Label, neoBLUE Intensity/Height (DOC 011561). Consignees are instructed to measure the light intensity of their devices and to document that information of the device using an adhesive label that is provided. The neoBLUE 3 system and its replacement panel sold today are not affected by this issue. If there are any questions regarding this advisory letter or the attached Technical Bulletin, please call Natus Technical Service at 888-496-2887.
Quantity in commerce: 1907 total (1413 in US and 494 international)
Distribution: worldwide
Product codes and lots: All distributed Natus neoBLUE 2 systems with LED PCB replacements received after February 16, 2012. For use only with neoBLUE devices manufactured between 2002 and 2007 (neoBLUE2)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0847-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0847-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-22

Product code LBI

K022196Class IINatus Blue Light Phototherapy UnitNatus Medical, Inc. / cleared 2002-09-19

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)