Events

Rappel de OPTIMA MR430S 1.5T - 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
    23769
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-05-11
  • 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
    Ge healthcare has recently become aware of a potential safety issue with gas venting. a site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients. there have been no injuries reported as a result of this issue. at this site a magnet heater probe connection became disconnected. this resulted in ice build-up within the magnet blocking the cryogen vent. since the vent was blocked by ice the later magnet quench caused gas to be vented into the magnet room.

Device

OPTIMA MR430S 1.5T - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)