Events

Rappel de Xhibit Central Station, software version 1.1.5

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ecomed 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-2016-RN-01459-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-11-16
  • 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-2016-RN-01459-1
  • 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
    Reports have been received of telemetry spo2 numerics dropping off the xhibit central display when using software version 1.1.5 with connectivity to telemetry. desaturation, high, and low limit alarms work normally. this problem can occur when the xhibit central station software version 1.1.5 is used in conjunction with a telemetry receiver for purposes of remote patient monitoring.Ecomed pty ltd has not supplied any telemetry receiver medical devices to the australian hospitals that are connected to software version 1.1.5 of xhibit central station.
  • Action
    Although there is no product affected in Australia, product correction is being undertaken by Ecomed Pty Ltd to support potential future use of telemetry functionality with the Xhibit Central System in relevant Australian hospitals. Ecomed will be contacting affected customers to perform a software update. This action has been closed-out 11/05/2017.

Device

Xhibit Central Station, software version 1.1.5
  • Modèle / numéro de série
    Xhibit Central Station, software version 1.1.5Serial Numbers: SLA1015F00831, SLA0916F02109ARTG Number: 237776
  • Manufacturer
    Ecomed Pty Ltd

Manufacturer

Ecomed Pty Ltd