Events

Rappel de INNOVA 4100IQ - 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
    151363
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2008-06-02
  • 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
    Jnexpected system lockups may occur while using the image auto-archiving function. if it occurs during x-ray imaging the acquisition fails and the user has to reset the system.

Device

INNOVA 4100IQ - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: 2335129 (Lot serial: MANUFACTURER); Model Catalog: 2335139-2 (Lot serial: MANUFACTURER); Model Catalog: S18741AM (Lot serial: CONTACT); Model Catalog: 2335139-2 (Lot serial: CONTACT); Model Catalog: S18741AM (Lot serial: >10 NUMBERS); Model Catalog: 2335129 (Lot serial: >10 NUMBERS); Model Catalog: 2335139-2 (Lot serial: >10 NUMBERS); Model Catalog: S18741AM (Lot serial: MANUFACTURER); Model Catalog: 2335129 (Lot serial: CONTACT); Model Catalog: 2335139-4 (Lot serial: 498680BU8 46582BU1 466841BU4); Model Catalog: S18751AP (Lot serial: 498680BU8 46582BU1 466841BU4); Model Catalog: S18751AP (Lot serial: S/N'S 7C20168 7C20305); Model Catalog: S18751AP (Lot serial: 498683BU2 7C20329 520071BU2); Model Catalog: 2335139-4 (Lot serial: S/N'S 7C20168 7C20305); Model Catalog: 2335139-4 (Lot serial: 498683BU2 7C20329 520071BU2)
  • Description du dispositif
    INNOVA 4100 IQ - MAIN UNIT
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)