Events

Retiro De Equipo (Recall) de CUSA EXCEL+ SYSTEM - CONSOLE

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

¿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
    107102
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-04-15
  • 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 cusa excel family of ultrasonic tissue ablators are used in surgical procedures where fragmentation emulsification and aspiration of soft and hard tissue is desirable. the excel family of devices is tested against standard 60601 for electrical safety fire and mechanical hazard compliance by underwriters laboratory (ul) against european standard ul and canadian requirements. however the three excel consoles that have been imported and distributed in canada do not have the required specific ul canada logo.

Device

CUSA EXCEL+ SYSTEM - CONSOLE
  • Modelo / Serial
    Model Catalog: CUSA EXCEL2 (Lot serial: HFB1100401IE); Model Catalog: CUSA EXCEL2 (Lot serial: HFL1004101IE); Model Catalog: CUSA EXCEL2 (Lot serial: HFL1004701IE)
  • Descripción del producto
    CUSA EXCEL + SYSTEM
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.