Events

Rappel de 1.5T SIGNA INFINITY TWINSPEED WITH EXCITE

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
    24038
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-09-09
  • 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
    Use of cadstream with "pure" software for dynamic mri imaging may require a modification to the study preference settings to present colour overlays equivalent to non-pure studies.

Device

1.5T SIGNA INFINITY TWINSPEED WITH EXCITE
  • Modèle / numéro de série
    Model Catalog: M3000TD (Lot serial: MANUFACTURER); Model Catalog: M3000TD (Lot serial: >10 NUMBERS); Model Catalog: M3000TD (Lot serial: CONTACT); Model Catalog: M3000LF (Lot serial: 274168MR4 270572MR1); Model Catalog: M7000BF (Lot serial: S/N'S 291192MR3 290992MR7); Model Catalog: M3000LF (Lot serial: S/N'S HDMR10368 7547YR3); Model Catalog: M3000LF (Lot serial: 278606MR9 266072MR8); Model Catalog: 2294302 (Lot serial: 253630MR8 239043MR3); Model Catalog: 2294302 (Lot serial: S/N'S 243409MR0 239046MR6); Model Catalog: 2294302 (Lot serial: 256216MR3 246610MR0); Model Catalog: 2294302 (Lot serial: 258415MR9 247728MR9); Model Catalog: 2294302 (Lot serial: 242181MR6); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: S/N 30BD4960); Model Catalog: M3333TA (Lot serial: S/N'S 6690YR2 266690MR7); Model Catalog: M3335PB (Lot serial: >10 NUMBERS); Model Catalog: M3335PB (Lot serial: CONTACT); Model Catalog: M3335PB (Lot serial: MANUFACTURER); Model Catalog: M3335JK (Lot serial: S/N 7555YR6)
  • Description du dispositif
    1.5T SIGNA INFINITY TWINSPEED EXCITE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)