Events

Rappel de Philips Intera 0.5T/1.0T/ 1.5T, Achieva 1.5T, Multiva 1.5T and Ingenia CX 1.5T

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia 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-00347-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-04-23
  • 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-2018-RN-00347-1
  • 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
    In rare cases, helium gas may escape into the examination room when superconductivity is lost (also known as quenching of the magnet) and at the same time the designed helium ventilation path is impeded. philips has become aware of one instance where this happened in a philips system. investigation found the metal burst disk assembly in the vent path did not perform according to specifications.
  • Action
    As an interim measure Philips is referring users to follow the relevant sections of the current IFU in the event helium gas escapes into the examination room during a magnet quench; and As a long term correction Philips will schedule an inspection of all MRI systems that may be affected by this issue and where applicable the spare 3” metal burst disk will be replaced during this inspection. Philips advises that planning will be carefully coordinated and where possible this correction will be done during off hours to reduce any disturbance to customers.

Device

Philips Intera 0.5T/1.0T/ 1.5T, Achieva 1.5T, Multiva 1.5T and Ingenia CX 1.5T
  • Modèle / numéro de série
    Philips Intera 0.5T/1.0T/ 1.5T, Achieva 1.5T, Multiva 1.5T and Ingenia CX 1.5TARTG Number: 230064(Philips Electronics Australia - MRI system, full-body, superconducting magnet)
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA