Events

Rappel de neoBLUE LED Phototherapy Lights (2nd Generation)

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-00466-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-26
  • 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-00466-1
  • 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
    The neoblue 2 systems were manufactured using individual leds of higher intensity output than the original product specification. to compensate for this higher intensity, customers were previously advised to increase the distance between the phototherapy light and the patient. the neoblue 2 light is now being recalled and replaced with the current generation light.
  • Action
    Paragon Care is requesting customers identify if they have affected stock by checking for a black band around the light enclosure base. If so, users are requested to record the Serial number (located on the back panel of the light enclosure) on the reply form and return the completed form in order to receive a free replacement. Users are then advised to place the affected light in the box which contained the replacement prior to its return to Paragon Care.

Device

neoBLUE LED Phototherapy Lights (2nd Generation)
  • Modèle / numéro de série
    neoBLUE LED Phototherapy Lights (2nd Generation)ARTG Number: 97472
  • Manufacturer
    Paragon Healthcare Pty Ltd

Manufacturer

Paragon Healthcare Pty Ltd