Events

Rappel de Philips Allura Systems, Actuator Monitor Ceiling Suspension (MCS)

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 Nederland BV.

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
    18800
  • Date de mise en oeuvre de l'événement
    2015-07-06
  • 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 received a report of a failing monitor ceiling suspension (mcs) actuator on an allura xper system. the actuator assembly had become detached and the monitor carriage with a flexvision monitor dropped to its lowest position., when the monitor ceiling suspension falls to its lowest position there is a possibility it might collide with a patient or personnel in the room. there is also the posssibility that the monitor ceiling suspension may collide with other equipment in close proximity to the mcs.
  • Action
    Product to be modified

Device

Philips Allura Systems, Actuator Monitor Ceiling Suspension (MCS)
  • Modèle / numéro de série
    Model: 722010, 722011, 722012, 722013, 722022, 722023, 722024 and 722015, Affected: All serial numbers
  • Manufacturer
    Philips Medical Systems Nederland BV

Manufacturer

Philips Medical Systems Nederland BV
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA