Events

Rappel de Stellaris PC with Laser System (Cataract extraction/vitrectomy 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 Bausch & Lomb 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-2014-RN-01205-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-13
  • 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-2014-RN-01205-1
  • 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 stellaris pc has a software fault, when in surgery, if the surgeon requests a laser sub-mode change (i.E. from endo to endo continuous) and the system is in “standby”, the system will automatically transition from “standby” to “ready” to fire. if the system moves to ready from standby, and this has not been specifically commanded by the surgeon or the nurse, it raises the possibility that this change may not have been noticed and that the foot pedal could be depressed and the laser may fire unexpectedly.
  • Action
    Bausch and Lomb has developed a software update to address the situation, which will be installed in the affected system. In the meantime, users may continue to use the Stellaris PC laser system. However, they are advised not to request the Laser sub-mode change from Endo to Endo Continuous during surgery until the software update has been implemented. This action has been closed-out on 06/06/2016.

Device

Stellaris PC with Laser System (Cataract extraction/vitrectomy system)
  • Modèle / numéro de série
    Stellaris PC with Laser System (Cataract extraction/vitrectomy system)Product Code: BL14304Serial Number : SPC02059ARTG Number: 127264
  • Manufacturer
    Bausch & Lomb Australia Pty Ltd

Manufacturer

Bausch & Lomb Australia Pty Ltd