Events

Rappel de Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iCT SP, Ingenuity Core, Ingenuity CT and MX8000 Dual v. EXP (Computed tomography diagnostic x-ray systems)

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-2013-RN-00038-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-01-15
  • 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-2013-RN-00038-1
  • 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
    Philips healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. philips has determined the cause was a malfunction of the vertical brake of the patient support due to embrittlement of the vertical brake’s screws.
  • Action
    If the couch moves down unexpectedly, please discontinue use of the device and contact your local Philips Field Service Engineer. A Philips Field Service Engineer will perform a brake repair or replacement on the affected systems to resolve the issue.

Device

Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iC...
  • Modèle / numéro de série
    Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iCT SP, Ingenuity Core, Ingenuity CT and MX8000 Dual v. EXP (Computed tomography diagnostic x-ray systems)Multiple serial numbers affectedARTG: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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