Retiro De Equipo (Recall) de MAGNUS HYBRID OPERATING TABLE COLUMNS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MAQUET-DYNAMED INC..

¿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
    26621
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-09-08
  • País del evento
  • 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
    A complaint with a system in which the inability to perform rotational angiography occurred twice. the cause was traced to a sensor in the magnus column as a result of an incorrect signal from this sensor all high-speed movements of the c-arc were blocked. an incorrect signal can have an effect during high-speed applications of the allura system (3dra xperct xperswing). if the fault occurs during daily xperct calibration this function will not be available. if the fault occurs prior to or during a high-speed application the acquisition cannot be set-up and the movement function of both the c-arc and the magnus operating table are locked. the described fault does not affect other functions of the system.

Device

  • Modelo / Serial
    Model Catalog: 1180.01A1 (Lot serial: 00023)
  • Descripción del producto
    MAGNUS Hybrid operating table columns
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
  • Source
    HC