Events

Rappel de Philips CDAS Intera MR Systems equiped with Basic Triggering Unit

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
    18027
  • Date de mise en oeuvre de l'événement
    2015-01-28
  • 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
    Affected lithium polymer batteries may fail after being physically dropped from a height (i.E. from waist height to floor). the failed battery may momentarily produce a flame and then emit smoke, which could lead to a thermal burn to patient or operator in close proximity to the battery. the failure of the battery may occur instantly or may be delayed for a short period of time.
  • Action
    Product to be exchanged

Device

Philips CDAS Intera MR Systems equiped with Basic Triggering Unit
  • Modèle / numéro de série
    Model: Part Number 9065 and 9067 Lithium Polymer Fiber Optic Module Batteries (for use with Philips Basic Triggering Set [452213224543], Monitoring Sensor Set [452213224623], Battery Set [452215033673] and Service Parts [453564099151]), Affected: All batteries with date codes 2808 or earlier
  • Manufacturer
    Philips Medical Systems Nederland BV

Manufacturer

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