Events

Retiro De Equipo (Recall) de SOFTWARE APPLICATION MODEL 2843 V 2.6

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BOSTON SCIENTIFIC CORPORATION.

¿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
    41665
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1998-12-16
  • 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
    Software defect could cause the defibrillators to stop delivering pacing therapy for up to 24 hours.

Device

SOFTWARE APPLICATION MODEL 2843 V 2.6
  • Modelo / Serial
    Model Catalog: (Lot serial: MODEL 2843 VARIOUS S/N'S)
  • Descripción del producto
    VENTAK AV III DR SOFTWARE MODEL 2843
  • Manufacturer
    BOSTON SCIENTIFIC CORPORATION

Manufacturer

BOSTON SCIENTIFIC CORPORATION
  • Dirección del fabricante
    ST-PAUL
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    HC