Events

Rappel de Radiometer TCM5 Flex Monitor (non-invasive blood gas monitor)

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-2016-RN-01264-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-23
  • 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-2016-RN-01264-1
  • 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 risk that the tcm5 monitor may not be compliant with the waterproof specification, ipx2, which is required for a homecare environment. the problem is caused by incorrect assembly and may allow water to enter into the monitor, which may pose a risk of electrical shock for the user. there have been no reports of injuries as a result of this issue.
  • Action
    Radiometer is advising users to stop use of the affected devices until they have been inspected and repaired where required by a Radiometer representative. A loan unit will be provided while the device is being repaired. This action has been closed-out on 17/05/2017.

Device

Radiometer TCM5 Flex Monitor (non-invasive blood gas monitor)
  • Modèle / numéro de série
    Radiometer TCM5 Flex Monitor (non-invasive blood gas monitor)Serial Numbers: below 393-500R0030N009ARTG Number: 140333
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd