Events

Rappel de ML 301 Examination Lamp

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medical & Optical Instruments 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-00217-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-03-14
  • 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-00217-1
  • 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 are reports that after an average usage period of seven years fatigue failure of the plastic joint may occur. the manufacturer has become aware that a joint on the spring arm may break either during use or when the spring arm is not in operation. if the joint breaks, the spring arm falls suddenly and without hindrance. in such a case there is a high risk of injury to the patient and other persons in the immediate vicinity.
  • Action
    End users are requested to inspect all units to determine if the swing arm has a plastic joint. If the joint is plastic the spring arm must not be used. A replacement spring arm will be provided for all affected units.

Device

ML 301 Examination Lamp

Manufacturer

Medical & Optical Instruments Australia Pty Ltd