Events

Rappel de SIGMA PACEMAKER SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDTRONIC 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
    25157
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    1999-09-28
  • 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
    Manufacturer's robotics process problem as extra energy was applied to the connector anchoring mechanism.

Device

SIGMA PACEMAKER SYSTEM
  • Modèle / numéro de série
    Model Catalog: SVVI103 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SD 200 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SVVI (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SVDD303 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SVDD300 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SVDD 300 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSVI103 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSVI100 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR306 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR303 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR300 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR203 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR200 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR 306 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR 303 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR 300 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR 200 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SS103 (Lot serial: ALL SERIAL NUMBERS); Model C
  • Description du dispositif
    SIGMA PACEMAKER SYSTEM
  • Manufacturer
    MEDTRONIC INC.

Manufacturer

MEDTRONIC INC.
  • Adresse du fabricant
    MINNEAPOLIS
  • Source
    HC