Events

Rappel de INNOVA IGS 520 IMAGE GUIDED 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 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
    133001
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-12-10
  • 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 innova system can unexpectedly stop delivering x-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. no injuries have been reported due to this issue. the innova system can unexpectedly stop delivering x-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. no injuries have been reported due to this issue.

Device

INNOVA IGS 520 IMAGE GUIDED SYSTEM - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: 2335129-4 (Lot serial: N/A); Model Catalog: 2335139-X (Lot serial: N/A); Model Catalog: 2335129 (Lot serial: N/A); Model Catalog: 2335129-5 (Lot serial: N/A)
  • Description du dispositif
    INNOVA IGS 520 IMAGE GUIDED SYSTEM - MAIN UNIT
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)