Events

Rappel de Philips HeartStart MRx Defibrillator/Monitor

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 (USA).

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
    19357
  • Date de mise en oeuvre de l'événement
    2015-11-10
  • 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
    Mrx model m3535a with software version f.03.06 and earlier, and model m3536a with version t.00.05 and earlier may stop the automated ready-for-use (rfu) test in an abnormal state when the device is turned off. if this occurs, the rfu indicator window displays a pattern that is not documented in the instructions for use or service manual. if this pattern appears and the device is turned on, it will revert the rfu back to an hourglass, indication that it is fully functional in all monitoring and therapy modes. there is no clinical risk if the device that has displayed this rfu pattern is turned on and put into service.
  • Action
    Software to be upgraded

Device

Philips HeartStart MRx Defibrillator/Monitor
  • Modèle / numéro de série
    Model: M3535A and M3536A, Affected: , Software version: F.03.06 and T.00.05 and earlier
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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