neoBLUE blanket LED Phototherapy System (2019-01-08)

Starting date:

January 8, 2019

Posting date:

February 8, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68986

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  Reason
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  Affected products

Affected Products

neoBLUE blanket LED Phototherapy System

Reason

This notification is related to a prior notification, October 2016, regarding the neoBLUE blanket LED Phototherapy System.  At that time, Natus Medical informed you of a potential issue of discoloration/degradation/melting of the fibre optic bundle at the pad connector which is inserted in the neoBLUE blanket light box.  Natus Medical completed a redesign of the device and is initiating this field action to replace those systems shipped from 2011 through march 21, 2016.  Newer systems shipped after March 21, 2016 do not need to be replaced.  Natus will provide an updated literature kit for each of the newer devices.

Affected products