Events

Rappel de CombiDiagnost R90

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Philips Medical Systems DMC GmbH.

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
    22314
  • Date de mise en oeuvre de l'événement
    2017-11-24
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Cause
    The manufacturer has become aware that in some combidiagnost deliveries the tube adapter-plate green/yellow protective earthing wire was removed, during gcf tubes assembly, spacers with different thickness are used to position pre-loc ring in respect to focal spot in specified distance., there is a potential of an electrical shock if following factors occurs:, 1. an electrical failure leads to an electrical potential on the adapter plate, 2. the earth resistance based on mechanical connection is beyond limit, 3. person removes the tube cover. (not allowed for the customer), 4. person touches the live wired part during exposure/fluoroscopy.
  • Action
    Product to be modified

Device

CombiDiagnost R90

Manufacturer

Philips Medical Systems DMC GmbH
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA