Events

Retiro De Equipo (Recall) de AERONEB PRO-X - CONTROLLER KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por AEROGEN 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
    25407
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-09-05
  • 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
    Aerogen has received a small number of complaints in relation to the mains power adapter manufactured by friwo gmbh and used in the aeroneb solo and pro nebuliser systems. the complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. however it cannot be ruled out that the adapter may fail during use. if the failure was to occur during use then the internal electrical components of the mains power adapter would become exposed to the user. therefore there is a potential risk of electric shock if the cover falls off during use with mains power turned on and the user makes contact with specific recessed components inside the adapter housing.

Device

AERONEB PRO-X - CONTROLLER KIT
  • Modelo / Serial
    Model Catalog: AG-PX1000-US (Lot serial: N/A); Model Catalog: AG-AP1040-US (Lot serial: N/A)
  • Descripción del producto
    AERONEB PRO X CONTROLLER
  • Manufacturer
    AEROGEN LTD

Manufacturer

AEROGEN LTD
  • Dirección del fabricante
    DANGAN
  • Empresa matriz del fabricante (2017)
    Aerogen Ltd.
  • Source
    HC