Events

Rappel de Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Masimo 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-2013-RN-00379-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-30
  • 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-2013-RN-00379-1
  • 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
    Masimo has identified a very small number of rad-8 devices that, when moved, can power off without the operator pressing the power button. if a change in power status goes unnoticed by the caretaker, a delay of care could result.This recall action was not notified to the tga before it was initiated by masimo australia.
  • Action
    Masimo is providing two options to the customers for correction and removal. The first option is to return the Rad-8 devices for Masimo for repair. The second option is for a biomedical engineer employed by a customer to repair the device in the field once qualified by Masimo to do so. This action has been closed-out on 11/02/2016.

Device

Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013
  • Modèle / numéro de série
    Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013Device Identifiers: 1844, 1959, 1961, 1963, 22042, 22595, 3446, 9019, 9049, 9073, 9165, 9174, 9190, 9212, 9224,1845, 1960, 1962, 1964, 9020, 9050, 9074, 9166, 9175, 9191, 9213, 9192, 9194, 9193, 9195ARTG Number: 138873
  • Manufacturer
    Masimo Australia Pty Ltd

Manufacturer

Masimo Australia Pty Ltd