Events

Retiro De Equipo (Recall) de GEM II DR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDTRONIC OF CANADA LTD..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    48621
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2000-02-16
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    Loss of telemetry and device output because of fractured solder joint.

Device

GEM II DR
  • Modelo / Serial
    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)
  • Descripción del producto
    GEM DR II
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Dirección del fabricante
    BRAMPTON
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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