Events

Rappel de DASH, PDM and Tram models (Multiparameter patient monitor) Manufactured between October 2010 and September 2012

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-00258-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-04
  • 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-00258-1
  • 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
    Ecg and respiration signal noise caused by dash, pdm and/or tram ecg cable connector movement may result in reduced ecg, respiration and arrhythmia detection performance.
  • Action
    End users have been provided with work around instructions to help mitigate the issue. GE Healthcare is currently in discussion with TGA as how to best expedite identification of, and prioritised correction of affected units. A follow-up letter will be forwarded once there is a consensus as to the process to be undertaken. This action has been closed-out on 12/02/2016.

Device

DASH, PDM and Tram models (Multiparameter patient monitor) Manufactured between October 2010 and ...
  • Modèle / numéro de série
    DASH, PDM and Tram models (Multiparameter patient monitor) Manufactured between October 2010 and September 2012Dash 3000/4000/5000Product codes: SHQ and SD0Patient Data Module (PDM)Product code: SA3Tram 451, 451N, 451M, 851, 851N, 451N5, 851N5Product codes: RT1, RT4, RT5, RT7, RT8, RTW, SCE and SBBARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd