CLASS II Device recall · Reported 31 Dec 2014 · FDA Enforcement Report

Replacement LED PCB Kit recalled by Natus Medical Incorporated

Natus Medical is recalling Replacement LED PCB Kit. The recall was initiated on 19 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll 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)

Quantity recalled1907 total (1413 in US and 494 international)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0847-2015
FDA event ID: 69820
Recalling firm: Natus Medical, Seattle, WA
Classification: Class II
Status: Terminated
Recall initiated: 19 Nov 2014
FDA classified: 22 Dec 2014
Reported: 31 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Nov 2014	Recall initiated by company
22 Dec 2014	Classified by FDA	+33 days
31 Dec 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

worldwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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)

Where was it sold?

worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Natus Medical

All 17

Reported	Class	Recall	Company	Reason	Where
10 Jan 2024Device	CLASS II	External Drainage System Collection recalled	Natus Medical	Sterility	Nationwide
10 Jan 2024Device	CLASS II	EDS 3 CSF External Drainage System recalled	Natus Medical	Sterility	Nationwide
28 Dec 2022Device	CLASS II	The Natus Cranial Access Kit is designed to be a complete recalled	Natus Medical	Sterility	Nationwide
19 Jul 2017Device	CLASS II	The Olympic Pasteurmatic recalled by Natus Medical Incorporated	Natus Medical	Other	Nationwide
10 May 2017Device	CLASS II	Second generation neoBLUE LED Phototherapy Light recalled	Natus Medical	Other	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide