Events

Rappel de Alcon LuxOR LX3 Microscope Floor Stand(used with LuxOR LX3 and Q-VUE LX3 Ophthalmic Microscopes 175mm and 200mm)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Alcon Laboratories Australia 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-00727-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-02
  • 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-00727-1
  • 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
    Alcon has observed that multiple shipments or forceful impact to a caster on a luxor lx3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base. during an in-facility transfer, should a caster break or detach from the base while the microscope arm is not in the most inward locked position, the unit may tip if the microscope arm is extended over the location of the broken caster. this may lead to the potential for physical injury from the microscope tipping or falling.To date, two incidents of physical injury have been reported overseas in conjunction with this issue.
  • Action
    Alcon will contact users to schedule an appointment to inspect and retrofit LuxOR LX3 units with new bases and/or an updated caster configuration. In the interim, users are advised to ensure the articulating microscope arm is placed in a stowed and locked position over the microscope base and protect the casters from forceful impact. (Refer to recall notification for further details). Users are to contact their Alcon technical representative if they need to transport their unit to an off-site location or have immediate concerns about their unit.

Device

Alcon LuxOR LX3 Microscope Floor Stand(used with LuxOR LX3 and Q-VUE LX3 Ophthalmic Microscopes 1...
  • Modèle / numéro de série
    Alcon LuxOR LX3 Microscope Floor Stand(used with LuxOR LX3 and Q-VUE LX3 Ophthalmic Microscopes 175mm and 200mm)Catalogue Number: 8065752560ARTG Number: 210550
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd