Events

Rappel de Achieva 3.0T and Ingenia 3.0T MR Systems with passive shielding in the rear wall

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-2016-RN-01389-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-10-24
  • 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-01389-1
  • 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
    For the achieva 3.0t and ingenia 3.0t mr systems on sites with rear wall passive shielding, the thickness and location of shielding material must be installed according to requirements provided by philips. in cases where the requirements are not followed, the distance between the passive shielding rear wall and magnet could be insufficient. an insufficient distance leads to stronger attraction forces between the magnet and the passive shielding, which may lead to shearing of the magnet vibration pads. in a worst case scenario there may be displacement of the magnet, which could possibly result in harm (crushing risk) to persons inside the mr room and located between the magnet and passive shielding wall. to date there has been one overseas report of the magnet shifting with no harm to users or patients. displacement of a magnet can also result in image quality issues and mechanical fitting problems with the table. these functional issues affect the clinical usage of the mr system.
  • Action
    Philips is advising customers that if the distance between magnet covers and finished rear wall is less than 1.3m, to contact Philips. In addition, Philips Field Service Engineers will be visiting all sites and checking this distance. If action is required, Philips will, as appropriate, replace the magnetic vibration pads and/or install seismic brackets. Depending on the circumstances, it may be advised that further clinical use of the MR system should not occur until after the installation corrections have been completed.

Device

Achieva 3.0T and Ingenia 3.0T MR Systems with passive shielding in the rear wall
  • Modèle / numéro de série
    Achieva 3.0T and Ingenia 3.0T MR Systems with passive shielding in the rear wallARTG Number: 98887
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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