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Health product recall

neoBLUE LED Phototherapy System and refurbished system (2016-07-01)

Starting date:
July 1, 2016
Posting date:
July 22, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-59480

Affected products

  1. neoBLUE LED Phototherapy System
  2. neoBLUE LED Phototherapy System (refurbished)

    Reason

    New information in the neonatal phototherapy literature indicates that caution may be warranted for the use of high intensity phototherapy for underweight neonates (

    Affected products

    A. neoBLUE LED Phototherapy System

    Lot or serial number

    Not applicable

    Model or catalog number

    010066

    010068

    010069

    010070

     

    Companies
    Manufacturer

    Natus Medical Incorporated,

    5900 First Avenue South,

    Seattle

    98108

    Washington

    UNITED STATES



    B. neoBLUE LED Phototherapy System (refurbished)

    Lot or serial number

    Not Applicable

    Model or catalog number

    010066R

    Companies
    Manufacturer

    Natus Medical Incorporated,

    5900 First Avenue South,

    Seattle

    98108

    Washington

    UNITED STATES


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