Events

Rappel de Philips Extended Brilliance Workstation (EBW)

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Philips Medical Systems (USA).

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
    13725
  • Date de mise en oeuvre de l'événement
    2012-10-29
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Cause
    The manufacturer advises that specific versions of ebw software may cause an incorrect display of patient information/annotation and may lead to misinterpretation. specifically:, 1) when translating the calcium scoring (cs) results into chinese, the percentile is not reported accurately., 2) in the calcium scoring (cs) protocol, the protocol is switched to mass score but the protocol name remains agatston., 3) spline measurement values do not update when adding control point (cp) and when changing the length of the line., 4) in the ct viewer (ctv) pet studies being loaded from remote with slope different than 1, appear incorrectly in 2d scene and are not displayed with the correct suv values., 5) loading pet images in the ct viewer (ctv) \ quick review from remote with slope different than 1, the images with the different slope appear incorrectly with wrong suv values in perception and in qr.
  • Action
    Software to be upgraded

Device

Philips Extended Brilliance Workstation (EBW)
  • Modèle / numéro de série
    Model: , Affected: Versions 4.0.2, 4.5.2 and 4.5.3 SNs: 12314, 13160, 14329, 14674 ,12142 and 13348
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

Philips Medical Systems (USA)
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA