Events

Retiro De Equipo (Recall) de RELIANCE ENDOSCOPE PROCESSOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por STERIS CANADA 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
    117703
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-09-12
  • 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
    The reliance endoscope processing system (reps) is intended for washing and high level disinfection of up to two manually pre-cleaned immersible reusable heat-resistantsemi-critical devices such as gi flexible endoscopes bronchoscopes and their accessories. steris corporation is providing an urgent product safety notice to inform affected customers of an important change in the reliance endoscope processing system instructions for use when processing fujinon g5 and g8 type flexible gi endoscopes. this notice excludes fujinon model ec-530h l and ec-530ls gi endoscopes and does not affect use of the reliance eps to process any other manufacturer's qualified endoscopes.

Device

RELIANCE ENDOSCOPE PROCESSOR
  • Modelo / Serial
    Model Catalog: MB3-XXXX (Lot serial: S/N: 3625606001-3608912002); Model Catalog: MB00-XXXX (Lot serial: S/N: 3625606001-3608912002)
  • Descripción del producto
    RELIANCE ENDOSCOPE PROCESSOR
  • Manufacturer
    STERIS CANADA CORPORATION

Manufacturer

STERIS CANADA CORPORATION
  • Dirección del fabricante
    QUEBEC
  • Empresa matriz del fabricante (2017)
    Steris Plc
  • Source
    HC