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
    101168
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-02-07
  • 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
    Innova operator manual states that the air kerma ratio between the "low" and "normal" mode of operation during fluoroscopy exposure shall remain below 50% of normal detail mode forfluoroscopy. ge healthcare became aware of a potential issue on a specific fluoro mode setting rdl (auto-exposure preference) for which the "low" to "normal" dose rate ratio might be higher than 50% at very low dose level (6.7 mgy/min versus limit at 43.8 mgy/min) with 7.5 fps and 15 fps. as a result this issue raised a regulatory non-conformance concern. ge healthcare has completed upgrades to all affected units through software field actions thereby correcting the issue.

Device

INNOVA 4100IQ - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)