Events

Rappel de Arjo-Huntleigh Concerto & Basic Shower Trolleys

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par ArjoHuntleigh AB.

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
    20193
  • Date de mise en oeuvre de l'événement
    2016-05-25
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Arjo New Zealand Limited, 34 Vestey Drive, Mt Wellington, AUCKLAND 1060
  • Cause
    There have been a number of complaints where the bolts under the stretcher have become loose. there has been one minor injury as a result of a patient falling related to these incidents. manufacturer investigated the issue and the conclusion was that he stretcher mounting bolts or stretcher tilting mechanism can become loose which may make the device unstable, providing a potential for risk to the patient or the caregiver. there is a risk the locking mechanism for the stretcher-tilt function may not engage properly, resulting in a patient falling to the floor., the issue relates to a batch of devices manufactured between 7th march 2014 and 20th april 2015.
  • Action
    Product to be modified

Device

Arjo-Huntleigh Concerto & Basic Shower Trolleys
  • Modèle / numéro de série
    Model: , Affected: batch of devices manufactured between 7th March 2014 and 20th April 2015.
  • Manufacturer
    ArjoHuntleigh AB

Manufacturer

ArjoHuntleigh AB
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    NZMMDSA