Events

Rappel de Amo STAR Excimer Laser System

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par AMO Manufacturing USA, LLC.

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
    15562
  • Date de mise en oeuvre de l'événement
    2013-10-30
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: AMO Australia Pty Limited (NZ), c/- Exel New Zealand Limited, 3 - 5 Westfield Place, Mt Wellington, Auckland
  • Cause
    There is the potential to result in loss of illumination due to an unexpected failure of a component under high use conditions of the oblique and ring illumination lamps. this issue can be traced to overheating of a specific component found in a limited amount of star systems, which can result in a burning smell coming from the laser system. it does not affect laser pulse delivery. the treatment can continue without illumination of the surgical field at the surgeon's discretion. since all treatment steps (pulse by pulse) are stored in non-volatile memory, in the event of treatment interruption, when illumination is restored the surgeon can resume the treatment at the point where it was interrupted.
  • Action
    Product to be modified

Device

Amo STAR Excimer Laser System

Manufacturer

AMO Manufacturing USA, LLC