Events

Rappel de DX-M

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par AGFA HEALTHCARE INC..

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
    23009
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2011-12-06
  • 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 dx-g or dx-m digitizer may stop during startup or during a cassette scan cycle and occasionally the images can be lost. at the time a reboot was required to get the system running again. no harm has been reported for this issue. the dx-g or dx-m digitizer may lock up during the cassette scan cycle without any further error messages. at the time reboot was required to get the system running again. no images get lost in this scenario. no harm has been reported for this issue. images did not arrive in the foreseen patient folder at the processing station. some of the lost images could be found in emergency folders and some images were lost completely. the emergency folders are not accessible to the user. in most instances there is a delay in diagnosis with potential retakes required.

Device

DX-M
  • Modèle / numéro de série
    Model Catalog: 1.0 (Lot serial: NIM_2311); Model Catalog: 5NBGQ (Lot serial: NIM_2311)
  • Description du dispositif
    DX-M DIGITIZER SYSTEM
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

AGFA HEALTHCARE INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Agfa-Gevaert NV
  • Source
    HC