Events

Rappel de G5 Mobile Receiver Manufactured between January 2016 and February 2017

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

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-2018-RN-00275-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-06
  • 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-2018-RN-00275-1
  • 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
    G5 mobile receivers manufactured between january 2016 and february 2017 may not adequately complete the power on sequence under specific conditions. specifically, when the receiver is turned on, the green loading bar on the initialization screen becomes stuck with no further progress. the user cannot clear this screen and the receiver cannot be used to track blood glucose values. this is due to a software defect affecting devices produced in the above timeframe, which renders the receiver unusable after shutting it down in a particular sequence. this is a detectable issue for users if they check the screen after turning it on. no adverse health consequences are anticipated if you make sure you have access to an alternative means of monitoring your blood glucose.
  • Action
    Emergo is advising users to contact Australian Medical Scientific (AMSL) to obtain a replacement receiver. Supplemental instructions will be provided to users as an interim measure to prevent this issue occurring until users receiver an updated receiver.

Device

G5 Mobile Receiver Manufactured between January 2016 and February 2017
  • Modèle / numéro de série
    G5 Mobile ReceiverManufactured between January 2016 and February 2017 ARTG Number:169241(Emergo Asia Pacific T/a Emergo Australia - Glucose monitoring system, in vivo)
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia