Events

Rappel de Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet. (used with pulse oximeter for the measurement of parameters such as arterial oxygen).

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-2015-RN-01074-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-09
  • 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-2015-RN-01074-1
  • 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 specific lots of sensors that were manufactured with incompatible configurations. this could result in sensors that will either not provide readings for the spco and spmet parameters or inaccurate readings. the specific behaviour will depend on the firmware version of the technology board in the device. spco measurements, when displayed, could be incorrectly elevated throughout the measurement range. spmet measurements above 6% could be affected by a negative bias of 1.5%, on average.
  • Action
    Masimo is advising users to inspect stock and quarantine any affected units for replacement with unaffected stock. This action has been closed-out on 18/08/2016.

Device

Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet. (used with pulse oxi...
  • Modèle / numéro de série
    Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet. (used with pulse oximeter for the measurement of parameters such as arterial oxygen). Reference: 2696 Lot Number: 15HA6Sensor Reference: 24087-A15G760 , 24087-A15H754ARTG Number: 157503
  • Manufacturer
    Masimo Australia Pty Ltd

Manufacturer

Masimo Australia Pty Ltd