Events

Retiro De Equipo (Recall) de INNOVA E4 WASHER - DISINFECTOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SCICAN 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
    147670
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-12-03
  • 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 products affected by this recall are the innova e4 washer-disinfectors manufactured by scican gmbh. this recall is being initiated as a result of a recent service of 4 units at one location which identified that the insert spacer on the lower loading rack of the trolley had come off 3 of the 4 units. this insert spacer is located on the trolley where flexible scopes are loaded. when this trolley is inserted into the unit this component slides a mechanism aside that blocks the flow of water and chemical when the trolley is not in place. without this component in place there is nothing to slide the mechanism aside and therefore no flow of chemical to reprocess the scope. while there have been no other reports of this nature it was imperative that all innova e4 units be inspected to ensure that the fitting is securely in place.

Device

INNOVA E4 WASHER - DISINFECTOR
  • Modelo / Serial
    Model Catalog: E4-WD (Lot serial: > 10 numbers contact mfg)
  • Descripción del producto
    INNOVA E4 WASHER-DISINFECTOR
  • Manufacturer
    SCICAN LTD.

Manufacturer

SCICAN LTD.
  • Dirección del fabricante
    TORONTO
  • Empresa matriz del fabricante (2017)
    Scican Ltd
  • Source
    HC