Events

Rappel de LIGHTSPEED 16 CT SCANNER SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    19375
  • Classe de risque de l'événement
    II
  • 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 three mounting bolts securing the power supply could have been over-torqued due to a service procedure error. in the unlikely event that the component becomes loose on the ct gantry during operation t could result in serious bodily injury if the component were to be expelled.

Device

LIGHTSPEED 16 CT SCANNER SYSTEM
  • Modèle / numéro de série
    Model Catalog: B7868JA/JD (Lot serial: 335314CN1); Model Catalog: B7868JA/JD (Lot serial: 389961CN4); Model Catalog: B7868JA/JD (Lot serial: 307018CN2); Model Catalog: B7868JA/JD (Lot serial: 318927CN1); Model Catalog: B7868JA/JD (Lot serial: 298660CN2); Model Catalog: B7868JA/JD (Lot serial: 329994CN8)
  • Description du dispositif
    LIGHTSPEED 16 CT SCANNER SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)