Events

Rappel de Ingenuity Core using software version 3.5.4 (Computed tomography (CT) x-ray diagnostic system)

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-00476-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-19
  • 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-00476-1
  • 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 received reports from the field that certain ingenuity core systems running software version 3.5.4 exhibited intermittent swirl-like ring artefacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images. a patient rescan may be required due to impairment of the diagnostic quality of the reconstructed images.
  • Action
    There are no proactive actions for the user. Clinical judgment should be used by the clinician to determine if the images contained in the dataset without artefacts contain enough information to make a diagnosis. If these images are sufficient, no further action is required. If the images are not sufficient, a rescan of the patient may be required. Philips Healthcare is implementing software update version 3.5.5 to correct the above-described issue. This action has been closed-out on 30/01/2017.

Device

Ingenuity Core using software version 3.5.4 (Computed tomography (CT) x-ray diagnostic system)
  • Modèle / numéro de série
    Ingenuity Core using software version 3.5.4 (Computed tomography (CT) x-ray diagnostic system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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