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
    71318
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-10-13
  • 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
    The patient support table top may fail to move in the horizontal direction when it is commanded to do so during ct scans due to a potential mechanical linkage failure. the system cannot automatically detect this failure to abort the scan or to alert the user. of the 5000 ct systems potentially affected there have been 2 occurrences of this failure mode in the past 10 years.

Device

BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: 4535 670 88051 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 4550 110 09021 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 4550 110 04011 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 728311 (Lot serial: 200071); Model Catalog: 453567005721 (Lot serial: 6149); Model Catalog: 453567005721 (Lot serial: 6150); Model Catalog: 728306 (Lot serial: 100195); Model Catalog: 728306 (Lot serial: 100223); Model Catalog: 4535 670 78851 (Lot serial: 6352); Model Catalog: 728306 (Lot serial: 100206); Model Catalog: 728306 (Lot serial: 100249); Model Catalog: 728306 (Lot serial: 100101); Model Catalog: 728306 (Lot serial: 100290); Model Catalog: 728306 (Lot serial: 100046); Model Catalog: 728306 (Lot serial: 100440); Model Catalog: 728326 (Lot serial: 30003); Model Catalog: 728326 (Lot serial: 30004); Model Catalog: 728323 (Lot serial: 30004); Model Catalog: 728323 (Lot serial: 320148); Model Catalog: 728326 (Lot serial: 320148); Model Catalog: 728323 (Lot serial: 320123); Model C
  • Description du dispositif
    BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT;BRILLIANCE 40/64 SLICE CT SYSTEM;BRILLIANCE ICT SP SYSTEM - MAIN;BRILLIANCE CT SYSTEM (16P);BRILLIANCE ICT SYSTEM - SYSTEM;BRILLIANCE 6/10/16 SLICE CT SYSTEM;INGENUITY CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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