Events

Rappel de BRILLIANCE ICT SP SYSTEM - MAIN

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
    67756
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2018-02-14
  • 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
    Upon closing the emergency stop (e-stop) the system performs an internal check. as a result of the motion controller in the couch there is a delay in the response to the internal check. this delay may cause the couch carbon top to enter a free float state which may allow it to move during patient load or unload activities. this free float motion results in the estop being opened due to the unexpected couch motion. this issue occurs frequently after closing e-stop. the motion controller in the couch detects a power problem and disables the horizontal motor which allows the couch top to free-float*. *the term free float refers to the couch top being in a state that is not locked in position by the brake or being moved in a controlled fashion (manual or automatic motion).

Device

BRILLIANCE ICT SP SYSTEM - MAIN
  • Modèle / numéro de série
    Model Catalog: 728311 (Lot serial: N/A); Model Catalog: 4535 670 88051 (Lot serial: N/A); Model Catalog: 728244 (Lot serial: N/A); Model Catalog: 728306 (Lot serial: N/A); Model Catalog: 728326 (Lot serial: N/A); Model Catalog: 728323 (Lot serial: N/A)
  • Description du dispositif
    BRILLIANCE ICT SYSTEM- SYSTEM;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