Events

Rappel de ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery). An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Radiometer Pacific 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-00805-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-27
  • 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-00805-1
  • 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
    Radiometer has recently become aware of a potential issue where a battery module had overheated caused by the continued charging of a collapsed battery cell. they have identified that worn battery modules with limited or no capacity manufactured in production runs below 910-311p0009nxxx are prone to cell collapses.
  • Action
    Radiometer is advising users that battery modules below 910-311P0009Nxxx will be replaced with a newly designed battery module. Radiometer is advising users with battery modules 910-311P0009Nxxx and above will be required to undertake 12 monthly checks of the capacity of the battery modules. This action has been closed-out on 11/08/2016.

Device

ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery). An...
  • Modèle / numéro de série
    ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery). An in vitro diagnostic medical device (IVD)Battery modules: below 910-311P0009NxxxAll serial numbers affectedARTG Number: 228382
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd