Events

Rappel de Arjo Quick Connect Scale used with Maxi Sky 2Manufactured between June 2016 and November 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 Arjo 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-2018-RN-00123-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-28
  • 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-00123-1
  • 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
    Arjo has received a limited number of complaints where it was noted there was a disconnection of the spreader bar from the quick connect scale.This occurence may result in users falling whilst the device is in use.
  • Action
    Arjo will be in contact with affected users to arrange for devices to be upgraded

Device

Arjo Quick Connect Scale used with Maxi Sky 2Manufactured between June 2016 and November 2017.
  • Modèle / numéro de série
    Arjo Quick Connect Scale used with Maxi Sky 2Manufactured between June 2016 and November 2017.Part Number: 700-19490Serial Numbers range 300142013 - 300219867Part Number: 700-19485 Serial Numbers range 300146551 - 300220716ARTG Number: 276363(Arjo Australia - Scale, patient, sling)
  • Manufacturer
    Arjo Australia Pty Ltd

Manufacturer

Arjo Australia Pty Ltd
  • Source
    DHTGA