Events

Rappel de Essenta DR Compact (Digital diagnostic X-Ray 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 Philips Electronics Australia 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-2012-RN-01094-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-10-29
  • 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-2012-RN-01094-1
  • 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
    1. the weight of the u-arm on the essenta dr compacta is counterbalanced by two parallel suspension springs in the column. when a single spring breaks, there is a risk that the safety catch mechanism may not activate due to the counteracting force of the remaining spring. as a result, the u-arm moves down uncontrollably. this was observed during reliability tests on the steel rope within the vertical carriage where one of the springs broke and the safety catch did not hold. in a post market risk assessment it was detected, the item can occur in the field by 2.5 years of operation. these 2.5 years are calculated for a worst case usage of the system.2. during in house testing it was detected that the lifetime of the wire rope for the vertical movement is significantly lower than 10 years specified in the instructions for use. if the rope breaks, the safety catch will hold the u-arm under all circumstances.
  • Action
    Philips Healthcare is replacing the vertical carriage, wire rope and Instructions for Use (IFU).

Device

Essenta DR Compact (Digital diagnostic X-Ray system)

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA