Events

Rappel de GE Dash 3000/4000/5000 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 Medical Systems Information Technologies.

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
    13319
  • 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 had advised that there are several potential issues with the dash 3000/4000/5000 patient monitors;, 1/ dash stops communication on the unity network resulting in loss of monitoring at the centra station, 2/ dash displays distorted ecg waveform in combination monitoring mode, 3/ dash incorrectly becomes time master on the unity network, 4/ dash date reverts to 1993, 5/ dashport 2 stops communicating on the unity network resulting in loss of monitoring at the central station.
  • Action
    Software to be upgraded

Device

GE Dash 3000/4000/5000 Patient Monitor

Manufacturer

GE Medical Systems Information Technologies