Events

Rappel de Dash 3000/4000/5000 (multiparameter patient monitor) & Dash Port 2 (docking station for Dash 3000/4000/5000)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia Pty Ltd.

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
    RC-2013-RN-00155-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-02-28
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00155-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Ge healthcare has identified several potential safety issues with the dash 3000/4000/5000 patient monitors and the dash port 2 docking station.The dash 3000/4000/5000 patient monitors may encounter the following issues:- dash stops communicating on the unity network resulting in loss of monitoring at the carespace cic pro central station.- dash displays distorted ecg waveforms in combination monitoring mode- dash date reverts to 1993the dash port 2 stops communicating on the unity network resulting in loss of monitoring at the carespace cic pro central station.
  • Action
    GE Healthcare is developing a software correction and will provide to customers once development has been completed. In the interim end users have been requested to follow work around instructions to help mitigate the issues. Thia action has been closed out on 28/01/2016.

Device

Dash 3000/4000/5000 (multiparameter patient monitor) & Dash Port 2 (docking station for Dash 3000...
  • Modèle / numéro de série
    Dash 3000/4000/5000 (multiparameter patient monitor) & Dash Port 2 (docking station for Dash 3000/4000/5000)Dash networked units with product codes EH, AAB, DSH, SBG, SHQ and SD0 in the serial number Dash Port 2 units with product code SE5 in the serial numberARTG number 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd