Events

Rappel de STELLANT WITH CERTEGRA WORKSTATION - STELLANT CT INJECTION SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BAYER MEDICAL CARE 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
    69529
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-06-12
  • 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
    A customer complaint was received indicating that the contrast phase of a p3t (personalize patient protocol technology) generated diagnostic protocol was skipped. during an analysis of the issue it was found that the protocol generated via p3t was not achievable by the stellant with certegra work station injector. the system informed the user via pop-up message "insufficient volume for programmed rate". the protocol on the injector head would then revert to the previous injection protocol but the display would continue to reflect the unachievable protocol to the technician. this could lead to a patient being injected with a different protocol than the technician intended. this situation only arises in stellant systems with certegra work stations with sofware version 100.60 or newer that have p3t software enabled.

Device

STELLANT WITH CERTEGRA WORKSTATION - STELLANT CT INJECTION SYSTEM
  • Modèle / numéro de série
    Model Catalog: 3032458 (Lot serial: 11036); Model Catalog: 3032458 (Lot serial: 11047); Model Catalog: 3032458 (Lot serial: 10493); Model Catalog: 3032458 (Lot serial: 10962); Model Catalog: 3032458 (Lot serial: 11295)
  • Description du dispositif
    STELLANT WITH CERTEGRA WORKSTATION - STELLANT CT
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

BAYER MEDICAL CARE INC.
  • Adresse du fabricant
    INDIANOLA
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    HC