Events

Rappel de Minstrel Patient Transfer Lift with Scale

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-2014-RN-00790-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-07-15
  • 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-2014-RN-00790-1
  • 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 received a limited number of reports where the bolt under the scale unscrewed from the scale. this issue may cause the spreader bar bolt to unscrew from the scale and detach the spreader bar from the device.
  • Action
    ArjoHuntleigh would like to provide the following options to ensure continued safety and performance of your Minstrel Lift. Option 1: The Minstrel Lift devices are close to their intended 10-year lifetime and ArjoHuntleigh would like to offer our customers a trade-in discount to purchase a new Minstrel ArjoHuntleigh patient transfer lift. Option 2: An ArjoHuntleigh Service Technician will install a new scale with added locking features, to your existing Minstrel Lift, free of charge. If Option 2 is chosen, ArjoHuntleigh want to remind you that the Minstrel lift is near its intended 10-year lifetime and it should not be used past its lifetime, including installation of the new scale.

Device

Minstrel Patient Transfer Lift with Scale
  • Modèle / numéro de série
    Minstrel Patient Transfer Lift with Scale Serial Numbers: MPLAT0502W1403, MPLAT0502W1404, MPLAT0504W1518, MPLAT0504W1519 ARTG number: 200785
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

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