Retiro De Equipo (Recall) de BIO-CONSOLE DRIVE UNIT (550)

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
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    Possibility of sparking charring & fires from the power cords because the power cord's prongs may crack & fail at/or inside the plug.


  • Modelo / Serial
    Model Catalog: 95208 (Lot serial: 8729 8622); Model Catalog: 95208 (Lot serial: S/N'S 8473 8466 8687 8607); Model Catalog: 95208 (Lot serial: 8184 8677); Model Catalog: ATLG110 (Lot serial: MANUFACTURER); Model Catalog: ATLG110 (Lot serial: CONTACT); Model Catalog: ATLG110 (Lot serial: >10 NUMBERS); Model Catalog: MAG100 (Lot serial: MAG1000594); Model Catalog: MAG100 (Lot serial: MAG1000019 MAG1000597); Model Catalog: MAG100 (Lot serial: MAG1000249 MAG1000644); Model Catalog: MAG100 (Lot serial: MAG1000043 MAG1000506); Model Catalog: MAG100 (Lot serial: S/N'S MAG1001017 MAG1000592); Model Catalog: 560 (Lot serial: MANUFACTURER); Model Catalog: 560 (Lot serial: >10 NUMBERS); Model Catalog: 560 (Lot serial: CONTACT)
  • Descripción del producto
  • Manufacturer


  • Dirección del fabricante
  • Empresa matriz del fabricante (2017)
  • 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