Events

Rappel de Radiometer TCM5 FLEX/ BASIC Transcutaneous 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-2018-RN-00299-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-04-13
  • 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-2018-RN-00299-1
  • 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 previously informed users that they had received reports that instruments sensitive to electromagnetic interference may be affected by tcm5 measurements (tga ref: rc-2018-rn-00081-1 and rc-2017-rn-01327-1).Radiometer has released the revised version of the instructions for use which includes a separate paragraph in the introduction section under “electromagnetic interference”. this amendment is included from the tcm5 instructions for use, 996-436, version 201801f, pages 5 and 6. the updated ifu mirror the actions for users identified in rc-2018-rn-00081-1.
  • Action
    Radiometer is advising users to discard previous revisions of the Instructions for Use and replace these with the new versions. Radiometer is working on a solution, which involves a hardware redesign of the TCM5 monitoring system, for this issue. Users will be contacted by their Radiometer representative when the final solution is available.

Device

Radiometer TCM5 FLEX/ BASIC Transcutaneous Monitor
  • Modèle / numéro de série
    Radiometer TCM5 FLEX/ BASIC Transcutaneous MonitorAll Serial NumbersARTG Number: 140333(Radiometer Pacific - Transcutaneous blood gas monitor)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd