Events

Rappel de GE Carescape B650 Patient 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 GE Healthcare Finland Oy.

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
    13321
  • Date de mise en oeuvre de l'événement
    2012-08-14
  • 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    The manufacturer advises there are several potential issues with this device;, 1/ the spo2 saturation limit alartm does not always active with the nellcor spo2, 2/ the device may enter into a constant reboot loop causing the monitor to reboot continuously., 3/ the device may reboot when connected to the unity id, 4/ the device may not update the software for power management card., 5/ an insecurely connected or faulty usb cable may cause the monitor to reboot., 6/ there may be printing delays with the prn50 printer, 7/ the device may reboot due to an x server freeze.
  • Action
    Software to be upgraded

Device

GE Carescape B650 Patient Monitor

Manufacturer

GE Healthcare Finland Oy