Events

Rappel de Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System (2RT)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ellex Medical 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-2016-RN-00301-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-22
  • 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-2016-RN-00301-1
  • 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 manufacturer has identified a potential defect in the fixed laser eye safety filter assembly for the above laser systems. under certain conditions there is potential for the glass of the safety filter optics to crack on their lower edge due to pressure applied on them by their retaining plate which in turn could damage the laser safety coating on the optics.The safety filter is located on the binocular mount of the delivery head, and is in the user’s optical viewing path and as such provides protection to the user’s eyes from any diffused reflected laser light during the laser treatment.There is a risk associated that if the above failure mode occurs, there is a remote possibility that during laser treatment the user could be exposed to any diffused reflected laser light.
  • Action
    Ellex Medical is advising users to check the affected devices to see if there is any green laser light visible while firing the laser. If so, remove the device from use and notify Ellex. Ellex will be replacing the filters on all affected systems with a newly designed filter. This action has been closed-out on 27/01/2017.

Device

Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System ...
  • Modèle / numéro de série
    Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System (2RT) Model Numbers: LP5532 and LR1532Multiple Serial Numbers affectedARTG Number: 106758 and 224484
  • Manufacturer
    Ellex Medical Pty Ltd

Manufacturer

Ellex Medical Pty Ltd