Events

Recall of neoBLUE blanket LED Phototherapy SystemsDevice Numbers:007301 neoBLUE blanket LED Phototherapy System with Large blanket/pad; AUS power cord 007302 neoBLUE blanket LED Phototherapy System with Small blanket/pad; AUS power cord

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Paragon Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00043-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00043-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    A potential issue of discolouration/degradation/melting of the fiber optic bundle at the pad connector which is inserted in the neoblue blanket light box has been identified. the manufacturer is in the process of confirming an updated neoblue blanket configuration which will not be susceptible to the degradation issue. (please note that the date of project completion is uncertain at this time.).
  • Action
    Paragon is requesting users to continue to check the fiber optic connection before use as described in the Technical Bulletin. Users are advised to refer to the Technical Bulletin for further important information and that they will be contacted for a replacement or upgrade when the updated configuration is available.

Device

neoBLUE blanket LED Phototherapy SystemsDevice Numbers:007301 neoBLUE blanket LED Phototherapy Sy...
  • Model / Serial
    neoBLUE blanket LED Phototherapy SystemsDevice Numbers:007301 neoBLUE blanket LED Phototherapy System with Large blanket/pad; AUS power cord 007302 neoBLUE blanket LED Phototherapy System with Small blanket/pad; AUS power cordSerial numbers up to and including xxxx004282 ARTG Number: 97472
  • Manufacturer
    Paragon Healthcare Pty Ltd

Manufacturer

Paragon Healthcare Pty Ltd