Events

Rappel de SIGNA HDXT 1.5T MR 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
    24577
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-05-14
  • 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
    For clariview and screen save from gvtk (gems visualization toolkit) viewer the mr product can generate image headers with nonunique series identifiers which when exported to some pacs systems results in the series being associated with the incorrect study on the pacs. the intended study will not have the correct series listed and an unintended study will have it listed instead. in all cases patient identifying annotation remains correct. the issue may result in an incorrect diagnosis from the study with mixed patient data if the series protocol and anatomy on the studies are similar and the annotation is not noticed. the conditions under which the issue is known to be possible require that the studies have identical time of day (identical hours minutes and seconds) and that the exams be on an affected model of pacs at the same time. this is possible with one scanner on different days or on different scanners on the same day.

Device

SIGNA HDXT 1.5T MR SYSTEM - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: 00000287469MR1); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: 00000284254MR0); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: 00000304797MR4); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: 00002UA2400LWN)
  • Description du dispositif
    SIGNA HDXT 1.5T MR SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)