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PUBLIC SAFETY RECORD 68935 OF 3,210,000

Natus Medical Incorporated
All distributed Natus neoBLUE 2 systems with LED PCB replacements received after February 16, 2012. For use only with neoBLUE devices manufa

Identify the exact product and model, inspect its condition and check the official safety notice before continued use.

Medical devicesGeneral HospitalEnglish · United StatesRecall date 2014-12-22

English: Product names, model codes, official notices and manufacturer text remain in the language of the authoritative source. EgoFile interface content is translated.

DATA PROVENANCE

What this page contains

Record type
Official safety notice
Responsible source
FDA
Verification
Data from an official public register
Source evidence
Identifier: 131593:Z-0847-2015
Last source check
2 August 2026
Indexing policy
Page is eligible for indexing
Important limitation

This record is not a user manual or confirmation of conformity for a specific variant.

Public data with attribution retained
100%profile completeness
PRODUCT WORKSPACE

One product. Everything in one place.

Official FDA record. Confirm the complete rating-label code before saving a serial number or following variant-specific instructions.

Exact brand and modelProduct categoryMarket and languageNamed sourceOfficial identifier
01Confirm the variant

Compare the complete model, regional suffix and label.

02Save and monitor

Keep warranty, history and safety alerts together.

03Get a safe answer

Use cited guidance or create a private EgoFile case.

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01
Quick start

Before first use

  1. Match the model, date code and identifying label to the official record.
  2. Read the official recall notice and manufacturer instructions before assembly or use.
  3. Keep proof of purchase, serial details and recall contact information available.
02
Daily use

Operate the product correctly

  1. Use the product only for its intended purpose and within stated age, load and environmental limits.
  2. Stop when a guard, fastener, restraint, cable or structural part is missing or damaged.
  3. Keep children and bystanders away from hazards described in the official notice.
03
Safety

Important precautions

  • Stop using a recalled product until the official remedy has been completed.
  • Do not improvise repairs, disable guards or substitute safety-critical parts.
  • Report fire, shock, injury, collapse or unexpected movement to the manufacturer and appropriate authority.
04
Maintenance

Maintain reliable operation

  • Inspect accessible fasteners, guards, cords, batteries and structural joints regularly.
  • Use only approved replacement parts and cleaning methods.
  • Recheck recall status after ownership transfer, repair or identification of a different model variant.
OFFICIAL SAFETY ACTION

Unit, Neonatal Phototherapy · Other

Confirm the complete model, date code and product label before following the corrective measure.

2014-12-22 · 131593:Z-0847-2015

Hazard: 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 int

Official measure: 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 Adviso

Open official safety record ↗
COMMON ISSUES AND SYMPTOMS

What the product may be indicating

These are general diagnostic paths for this product category. Error-code numbers differ between brands, markets and revisions, so EgoFile shows a code only after it is confirmed in the exact official manual.

Source policySafe checks are maintained by EgoFile and linked to the official source record. No third-party manual text is copied.
01RECALL

Product matches a safety notice

High priority

What it means: The model, date code or product description may be subject to an official corrective action.

First safe check: Stop use and compare the complete identifying label with the official notice.

Stop condition: Follow only the official refund, repair, replacement or disposal remedy.

02DAMAGE

Visible damage or deformation

High priority

What it means: Cracks, loose joints, exposed wiring or distorted parts can defeat the intended safety design.

First safe check: Isolate the product and photograph the damage without dismantling it.

Stop condition: Do not reuse until the manufacturer confirms a safe remedy.

03PARTS

Part, guard or fastener is missing

Medium priority

What it means: The product may be incomplete, incorrectly assembled or affected by a component failure.

First safe check: Stop use and compare the assembly with the official parts and safety information.

Stop condition: Use only manufacturer-approved replacement parts and procedures.

04LABEL

Model or date code cannot be confirmed

Medium priority

What it means: A similar-looking product may not be covered by the same instructions or recall.

First safe check: Locate every rating label, serial number and date code before taking action.

Stop condition: Contact the manufacturer or CPSC when identification remains uncertain.

05INCIDENT

Fire, shock, injury or unexpected movement

High priority

What it means: A serious incident or near miss may indicate an immediate product hazard.

First safe check: Move people away, isolate energy only if safe and preserve the product for assessment.

Stop condition: Seek emergency help when needed and report the incident to the manufacturer and authority.

QUICK CHECKS

Three additional checks

Use these checks when no error code is displayed.

Product may match a recall

Compare the complete label and follow the official remedy.

Part is loose or damaged

Stop use and contact the manufacturer before repair or replacement.

Model cannot be confirmed

Do not rely on this summary; verify the label with the official source.

PUBLIC SAFETY CHECK

Check recalls separately from the manual.

No exact model match was attached automatically. Search the official safety records by brand, shorter model number or UPC.

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Exact variant check

This page summarizes an official safety record and corrective measure. Confirm the full model, date code and label before taking action.

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