Events

Rappel de IMPAX

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
    93577
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-11-25
  • 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
    When using the extended addendum workflow in impax 6.5.X and above with embedded reporting there is potential for loss of report text when validating addendums. this occurs when all of the conditions listed below happen at the same time: - the dictation or report text is not started as intended at the initial cursor location and - the keyboard arrow keys mouse or speechmike input are used to move the cursor in the addendum before dictating or typing report text and - the "reportstatus" bookmark is used to automatically add the status to the addendum and - with respect to impax 6.5.4 and prior 6.5.X versions the "beginprotect" and "endprotect" bookmarks have not been used to protect the "reportstatus" bookmark. if all of the above conditions are met and the cursor is placed at the "reportstatus" bookmark location when starting to dictate or type report text impax will overwrite the text entered at the "reportstatus" bookmark location with the addendum status when the addendum is validated. as a result some of the text of the addendum is not saved in the validated addendum.

Device

IMPAX
  • Modèle / numéro de série
    Model Catalog: 6.X (Lot serial: IMPAX 6.5.x and above)
  • Description du dispositif
    IMPAX
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

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