Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Replacement LED PCB Kit Recalled by Natus Medical Incorporated Due to Replacement LED Board kit of Natus neoBLUE2 Phototherapy...

Date: November 19, 2014
Company: Natus Medical Incorporated
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Natus Medical Incorporated directly.

Affected Products

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

Quantity: 1907 total (1413 in US and 494 international)

Why Was This Recalled?

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.

Where Was This Sold?

worldwide

About Natus Medical Incorporated

Natus Medical Incorporated has 18 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report