Events

Rappel de INSTATRAK 3500 PLUS SYSTEM

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
    151165
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2011-03-30
  • 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 customer labelling for transmitter sensor cables and receiver sensor cables states that the cables can be sterilized with the sterrad sterilization system. at the initial release of these products the only sterrad method was the 100s model. sterrad has since introduced the 100nx and nx models. the transmitter sensor cable and receiver sensor cable have been validated for sterilization in the sterrad 100s sterilizer and ethylene oxide (eto) sterilizers only. these products have not been validated for use in any other sterrad sterilizer. ge oec medical systems inc. internal testing has shown the high concentration of hydrogen peroxide used in the sterrad 100nx sterilizer is not compatible with some of the materials used in the transmitter sensor cable which may result in the degradation of the material. this could lead to a sterilization issue. testing shows that the receivers are not affected by the change in sterilization.

Device

INSTATRAK 3500 PLUS SYSTEM
  • Modèle / numéro de série
    Model Catalog: 1007907-NAV (Lot serial: ALL); Model Catalog: 1007914-NAV (Lot serial: ALL); Model Catalog: 1001989 (Lot serial: ALL); Model Catalog: 1002008 (Lot serial: ALL); Model Catalog: 1001990 (Lot serial: ALL); Model Catalog: 1004069 (Lot serial: ALL)
  • Description du dispositif
    INSTATRAK 3500 PLUS - Sensor Cables
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)