Events

Rappel de ArjoHuntleigh Flowtron ACS900 Active Compression System Flowtron ACS900 pumps manufactured between 26 Sept 2014 and 20 Dec 2016 with software V1.099

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Huntleigh Healthcare 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-2017-RN-00786-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-06-26
  • 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-2017-RN-00786-1
  • 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
    Arjohuntleigh has identified that in some instances specific acs900 pumps will constantly deliver pressure to the garment without triggering the alarm. an investigation has concluded that the consistent flow of pressure to the garment without deflation may lead to a potential risk of injury to patients. arjohuntleigh has received a limited number of complaints regarding this specific state.
  • Action
    ArjoHuntleigh is requesting that customers: 1. Ensure that all caregivers and users of the ArjoHuntleigh Flowtron ACS900 pump are made aware of this recall for product correction and that all listed devices at their facility are available to be upgraded during the service technician visit; 2. Complete, sign and return the Customer Response Form to ArjoHuntleigh. Note: ArjoHuntleigh will contact the designated facility representative listed on the Customer Response Form to schedule service to upgrade the software on all listed devices, free of charge.

Device

ArjoHuntleigh Flowtron ACS900 Active Compression System Flowtron ACS900 pumps manufactured betwee...
  • Modèle / numéro de série
    ArjoHuntleigh Flowtron ACS900 Active Compression SystemFlowtron ACS900 pumps manufactured between 26 Sept 2014 and 20 Dec 2016 with software V1.099Serial Number range: 1400028031 to 1600048470ARTG Number: 254916
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA