Events

Rappel de GE CareScape Patient Monitor, Multi-Parameter

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
    16868
  • Date de mise en oeuvre de l'événement
    2014-06-24
  • 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
    When connecting the pdm (patient data module) to the carescape b850, b650 or b450 monitor with software version 2 the pdm may not start communicating to the monitor and loss of the pdm parameters could occur., this issue happens after the following sequence of events:, 1. the pdm is connected to a transport pro or solar monitor., 2. at least one arrhythmia or st-change snapshot is saved in the pdm., 3. the pdm is then connected to the carescape bx50 monitor., 4. more than 740 arrhythmia or st-change snapshots are then saved in the pdm., 5. the pdm is then disconnected and connected back to the carescape bx50 monitor.
  • Action
    Software to be upgraded

Device

GE CareScape Patient Monitor, Multi-Parameter
  • Modèle / numéro de série
    Model: Models: B850, B650, B450, Affected: , Software version: Version 2 software
  • Manufacturer
    GE Healthcare Finland Oy

Manufacturer

GE Healthcare Finland Oy