Events

Rappel de Abbott Medical Optics (AMO) STAR Excimer Laser System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par AMO 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-2013-RN-00567-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-06-14
  • 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-2013-RN-00567-1
  • 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
    There is the potential for an inadvertent laser firing with no surgeon interaction on the foot pedal due to incorrect output of electrical foot switch buffer when the following conditions are present:1- circuit breaker c9 is tripped open, causing a remote panel pcb power loss2- normal system interlocks are cleared (system waiting for surgeon intervention)there have been no reports of inadvertent firing of the laser in the field.
  • Action
    Abbott Medical Optics is replacing the circuit board component of all STAR Excimer Laser Systems. The manufacturer has advised that the devices may continue to be used to treat patients. In the unlikely event that the system initiates treatment without direct input, physicians are advised to immediately use the Laser Stop Button located on the doctor's panel as described in the Operators Manual.

Device

Abbott Medical Optics (AMO) STAR Excimer Laser System
  • Modèle / numéro de série
    Abbott Medical Optics (AMO) STAR Excimer Laser SystemModels: S3, S4 and S4 IR
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd