Events

Rappel de PHILIPS MX 16-slice CT System, software: v1.1.3.1167; v1.1.4.21425; v1.1.4.21424; v1.1.4.21422

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-01105-1
  • Classe de risque de l'événement
    Class II
  • 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-01105-1
  • 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
    The orientation of images is displayed incorrectly. when operator chooses “gantry on the right side” from operation console, and the patient position is hfdl, hfdr, ffdl or ffdr, the patient position picture and text is not consistent. "l" and "r" of scan images are reversed and this is not consistent with the patient actual position. this issue may result in potential misdiagnosis or incorrect anatomy classification leading to unnecessary treatment/procedure.
  • Action
    Philips is providing temporary work around instructions in the customer letter until updated software in a Service Pack is installed in the affected systems. The Service Pack will also correct the following other issues: - When a surview which is longer than 557mm is stopped by using “Abort” function during the scan process, the position of scan box in surview image is not correct. - For dental applications, when a patient scan is taken with Gantry tilted, and the tilt angle falls in the range from 1 to -1 degree (not including 0 degree position), the data post-processing may not operate normally and the images may not be displayed. - If the user stops a surview using the “Abort” function during the second part of the scan, the positions of the scan box are not consistent. This action has been closed-out on 09/08/2016.

Device

PHILIPS MX 16-slice CT System, software: v1.1.3.1167; v1.1.4.21425; v1.1.4.21424; v1.1.4.21422
  • Modèle / numéro de série
    PHILIPS MX 16-slice CT System, software: v1.1.3.1167; v1.1.4.21425; v1.1.4.21424; v1.1.4.21422ARTG number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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