Events

Rappel de BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PHILIPS ELECTRONICS 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
    32304
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2018-01-05
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 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: issue #1: efov (extended field of view) check message does not display when fov is set >600mm for a paused scan issue #2: prefer "center x/y 0" and "disable result rotation" checkboxes checked automatically when checking the "ct simulation" issue #3: tumor loc allows poi (point of interest) locking when a non-isocenter slice is displayed issue #4: tracker scan completed no images were generated issue #5: continuous link plans the clinical scan outside the surview issue #6: applying tilt on first mpr result when the other axial results are unplanned causes change in scan length and number of cycles of scan issue #7: "system is still initializing. please wait." error issue #8: auto locations not functioning as expected issue #9: system ended exam before completion issue #10: system freeze-up after pause is pressed (for french translation please see e-file).

Device

BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: 728244 (Lot serial: N/A)
  • Description du dispositif
    BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Philips
  • Source
    HC