Events

Rappel de Brilliance CT series (6, 10, 16, 16 Power, 40, 64, Big Bore, iCT, iCT SP), Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, MX8000 Dual v. EXP

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-2014-RN-00475-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-24
  • 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-2014-RN-00475-1
  • 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 have found that if the service latch is not properly secured during servicing of the device, the table top's subframe becomes free floating causing unintended horizontal motion during use. there is a risk of serious injury to the patient and operator/technician as a result of the table top free floating. for the patient: - there is a potential for disconnection or movement of invasive medical devices such as i.V.’s, tracheostomies, and surgical drains for the operator/technician: - there is a potential for pinch point on the subframe; and - a potential for entrapment between the table and the gantry if the operator/technician stands between them to shift the patient forward.
  • Action
    Philips is advising their customers to contact their Field Service Engineer, if horizontal free-floating couch motion is experienced. This action has been closed-out on 11/04/2016.

Device

Brilliance CT series (6, 10, 16, 16 Power, 40, 64, Big Bore, iCT, iCT SP), Ingenuity CT, Ingenuit...
  • Modèle / numéro de série
    Brilliance CT series (6, 10, 16, 16 Power, 40, 64, Big Bore, iCT, iCT SP), Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, MX8000 Dual v. EXPARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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