Events

Rappel de Radiometer TCM4 series analyser base units (Transcutaneous and non invasive blood gas analysers)

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-2012-RN-01207-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-12-07
  • 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-2012-RN-01207-1
  • 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 become aware that specified tcm4 series base units do not comply with the medical safety standard iec 60601-1, 2nd edition, subclause 15(b).The implication is that there is a potential risk of receiving an electric shock under certain conditions as follows:the monitor is connected to the mains outlet and the mains switch is on; the battery is fully charged (or no battery is present); the operator disconnects the line cord (at either end) without first switching the mains switch on the back of the monitor to off; the operator touches the two metal pins on the mains plug or on the monitor's line cord receptacle after disconnecting the line cord.
  • Action
    Radiometer is informing users of the issue and is providing fluorescent warning stickers to be placed on the device and work around instructions to mitigate the risk if the device must be used. A hardware correction is forthcoming to permanently correct the problem.

Device

Radiometer TCM4 series analyser base units (Transcutaneous and non invasive blood gas analysers)
  • Modèle / numéro de série
    Radiometer TCM4 series analyser base units (Transcutaneous and non invasive blood gas analysers)Multiple item numbers and serial numbersARTG Numbers: 119074, 133015 & 133014
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd