Events

Rappel de OLS-500 & OLS-700 surgical lightsAll OLS500/OLS700 lights manufactured and installed since January 2015 may be affected.

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par ClaveGuard 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-2015-RN-00989-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-07
  • 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-2015-RN-00989-1
  • 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
    Claveguard ols-500 & ols-700 surgical lights manufactured since january 2015 have potential for the locating pin on the light handle to become detached in the event the restraining grub screw works loose.
  • Action
    Dickson & Dickson Healthcare are inspecting all affected systems to ensure the correct installation of the locating pin and perform any corrections required. This action has been closed-out on 18/08/2016.

Device

OLS-500 & OLS-700 surgical lightsAll OLS500/OLS700 lights manufactured and installed since Januar...
  • Modèle / numéro de série
    OLS-500 & OLS-700 surgical lightsAll OLS500/OLS700 lights manufactured and installed since January 2015 may be affected. ARTG Number: 198978
  • Manufacturer
    ClaveGuard Pty Ltd

Manufacturer

ClaveGuard Pty Ltd
  • Source
    DHTGA