Events

Rappel de Depuy Synthes Universal Battery Charger II (UBC II)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-2016-RN-00175-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-11
  • 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-2016-RN-00175-1
  • 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 ubc ii has a component which may fail prematurely due to a manufacturing defect. if the component fails, the charger’s firmware recognises the malfunction and prevents batteries from being charged. the blue led on the front of the charger will flash to indicate that the device must be sent in for repair, in accordance with the user’s manual. when component failure occurs, the device firmware causes the ubc ii to enter “safe mode” which prevents the batteries from charging; this could potentially lead to a surgical delay.
  • Action
    JJM is advising users to quarantine any affected stock prior to return and replacement. Users are advised to use alternate chargers or non-battery operated tools until a replacement is received.

Device

Depuy Synthes Universal Battery Charger II (UBC II)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes