Events

Rappel de 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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Paragon Healthcare Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00043-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-19
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00043-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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...
  • Modèle / numéro de série
    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