Events

Rappel de Brilliance Big Bore Oncology CT, Brilliance Big Bore Radiology CT with software version 4.2.0Used with associated Pinnacle3 Tumor LOC server (version 14.0)

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-2018-RN-00085-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-01-30
  • 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-2018-RN-00085-1
  • 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 of issues with brilliance big bore ct systems running software version 4.2.0. the most significant issues are:1- efov (extended field of view) check message does not display when fov is set >600mm for a paused scan2- prefer “center x/y 0” and “disable result rotation” checkboxes checked automatically when checking the "ct simulation"3- tumor loc allows poi (point of interest) locking when a non-isocenter slice is displayed4- tracker scan completed, no images were generated5- continuous link plans the clinical scan outside the surview6- applying tilt on first mpr result, when the other axial results are unplanned causes change in scan length and number of cycles of scan7- “system is still initializing. please wait…” error8- auto locations not functioning as expected9- system ended exam before completion10- system freeze-up after pause is pressed.
  • Action
    Philips is releasing a Field Change Order (FCO) to correct these issues. A Philips Field Service Engineer will contact users to schedule the FCO updates. In the interim, users are advised to refer to the Customer Letter for respective actions in regards to the outlined issues.

Device

Brilliance Big Bore Oncology CT, Brilliance Big Bore Radiology CT with software version 4.2.0Used...
  • Modèle / numéro de série
    Brilliance Big Bore Oncology CT, Brilliance Big Bore Radiology CT with software version 4.2.0Used with associated Pinnacle3 Tumor LOC server (version 14.0)ARTG Number: 98868 (Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body)
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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