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

Class II FDA enforcement event 72017. Recall start date: 5 Aug 2015. Status in the FDA record: Terminated. Termination date: 17 Mar 2016.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Natus Medical Incorporated started this device recall on 5 Aug 2015. The firm address in the FDA record is in Seattle, WA. FDA put the recall in Class II. FDA event 72017 has 1 product record. The first FDA enforcement report date is 28 Oct 2015. The record gives the status Terminated, with the termination date 17 Mar 2016.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution.

Recalling firm

Natus Medical Incorporated, Seattle, WA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 72017: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0149-2016	Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103	4560 units	Class II	Terminated	28 Oct 2015

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 16

Other events of the firm

Other FDA enforcement events of Natus Medical Incorporated
Initiated	Product (first record)	Type	Class	Records
28 Nov 2023	External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only	Device	Class II	2
18 Nov 2022	The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set t	Device	Class II	1
22 May 2017	The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of res	Device	Class II	1
3 Apr 2017	Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top	Device	Class II	1
28 Oct 2016	Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbiliru	Device	Class II	1
16 Sep 2016	Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used i	Device	Class II	1
25 Aug 2016	The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX00	Device	Class II	1
22 Apr 2016	Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 1	Device	Class II	1
11 Apr 2016	Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040	Device	Class II	1
8 Jan 2016	Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.	Device	Class II	1

Natus Medical Incorporated: all 16 events

Official channels

FDA enforcement report Z-0149-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 72017. https://recallregister.com/fda/ii/72017/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution.
What quantity of product is in FDA event 72017?: The FDA record gives this quantity: 4560 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.