Events

Rappel de Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option and have been upgraded from Software Version 3.x to Version 4.0.0 / 4.0.1

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-01100-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-10-10
  • 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-01100-1
  • 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 became aware through a customer complaint that while performing a cct examination on an ingenuity ct system, the first image was marked as “last shot” rather than the actual “last shot” acquired. after the clinician pressed the pedal for first exposure, images were displayed as the “last shot”. subsequent pedal presses did not result in immediate image reconstruction and the first image remained on the screen labelled as the “last shot”. eventually all images appeared. during an interventional procedure, there is a risk of serious injury to the patient if the clinician does not have real-time feedback of needle placement when the needle is near vital structures (major blood vessel, organ, etc).
  • Action
    Philips is advising that affected users should check their CCT exam card and correct if the issue exists as described in the instructions supplied with the customer letter. A Philips Field Service Engineer will contact customers to schedule the software update at their site to permanently correct the issue. This action has been closed-out on 05/09/2016.

Device

Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option ...
  • Modèle / numéro de série
    Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option and have been upgraded from Software Version 3.x to Version 4.0.0 / 4.0.1ARTG number: 98868
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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