Events

Rappel de REVOLUTION CT - 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
    75441
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-08-23
  • 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
    The following issue is being addressed by ge healthcare file no. 25470. the revolution ct exceeds iec conducted emission requirements. during recent certification testing ge healthcare determined that one configuration of the revolution ct product exceeds the conducted emissions limits specified in the iec60601-1-2:2007 emc standard. medical devices powered on the same power line as the revolution ct power distribution unit (pdu) may be affected by electrical emissions through the power line. equipment powered from the ct system such as the ekg monitor or patient contrast injector are not affected.

Device

REVOLUTION CT - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)