Events

Rappel de GEM II DR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDTRONIC OF CANADA LTD..

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
    48621
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2000-02-16
  • 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
    Loss of telemetry and device output because of fractured solder joint.

Device

GEM II DR
  • Modèle / numéro de série
    Model Catalog: 7273 (Lot serial: PJK200606H PJK200989H); Model Catalog: 7273 (Lot serial: PJK202209H PJK200857H); Model Catalog: 7273 (Lot serial: PJK200853H PJK201834H); Model Catalog: 7273 (Lot serial: PJK200322S PJK200611H); Model Catalog: 7273 (Lot serial: PJK200174H PJK200214H); Model Catalog: 7273 (Lot serial: PJK200743S PJK201835H); Model Catalog: 7273 (Lot serial: PJK200522S PJK200607H); Model Catalog: 7273 (Lot serial: PJK200346S PJK200521S); Model Catalog: 7273 (Lot serial: PJK200762S PJK200768S); Model Catalog: 7273 (Lot serial: PJK200415S PJK200305S); Model Catalog: 7273 (Lot serial: PJK201838H PJK201883H); Model Catalog: 7273 (Lot serial: PJK200424S PJK201837H); Model Catalog: 7273 (Lot serial: PJK200520S PJK201922H); Model Catalog: 7273 (Lot serial: PJK200310S PJK200524S); Model Catalog: 7273 (Lot serial: PJK200526S PJK200528S); Model Catalog: 7273 (Lot serial: PJK201815H PJK202178H); Model Catalog: 7273 (Lot serial: PJK200323S PJK200696S)
  • Description du dispositif
    GEM DR II
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Adresse du fabricant
    BRAMPTON
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC