Events

Rappel de Philips Essenta DR Digital X-Ray, C-arm

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
    15878
  • Date de mise en oeuvre de l'événement
    2013-12-17
  • 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
    If during system installation, the screws holding the c-arm were mounted using thread locking compound (e.G. loctite), then the corresponding thread inserts inside the c-arm casting may loosen when the c-arm is dismantled. if, after reassembly of the system, the loosened thread inserts become detached from the casting, the c-arm would no longer securely held in position and could fall. the c-arm is most often dismantled and reassembled when the system is moved to another location.
  • Action
    Product to be modified

Device

Philips Essenta DR Digital X-Ray, C-arm

Manufacturer

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