Events

Rappel de MultiDiagnost Eleva Flat Detector (FD) System(Diagnostic fluoroscopic digital X-ray 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-2015-RN-00070-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-01-29
  • 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-2015-RN-00070-1
  • 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 healthcare has discovered through customer complaints and internal testing an intermittent electronic product defect. in the md eleva system, software license keys are used to enable particular functionality. in software release r6.1.1sp2 and r6.1.2 intermittently part of the software keys are not loaded: - the license key for spectral filter- the license key for full table tilt range.
  • Action
    Philips Healthcare is recommending a system restart that may solve both issues when the software keys are not loaded. Philips Healthcare is providing the following instructions to identify the defects: If the license key for spectral filter is not loaded: once an EPX with half-dose is selected the incomplete dose reduction can be noticed via the actual skin dose (rate) displayed on the image monitor and the actual filter selection is displayed on the examination monitor. If the license key for full table tilt range is not loaded: The tilt movement stops at -20 degrees. This can be observed while preparing the room. Philips Healthcare released a software update and organising Philips field service engineers to install Software release R6.1.3 which addresses the non-loading of the Software license keys. This action has been closed-out on 08/08/2016.

Device

MultiDiagnost Eleva Flat Detector (FD) System(Diagnostic fluoroscopic digital X-ray system)
  • Modèle / numéro de série
    MultiDiagnost Eleva Flat Detector (FD) System(Diagnostic fluoroscopic digital X-ray system)Product Code: 708037ARTG Number: 98560
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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