Events

Retiro De Equipo (Recall) de E.CAM SIGNATURE SERIES

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

¿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
    54587
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-03-01
  • 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
    As a result of user error complaints regarding injuries resulting from collimator change siemens has determined that for e.Cam or symbia e systems although the existing user manual is correct additional supplemental instructions with the inclusion of visual aids may further clarify and emphasize the proper collimator change process. a customer advisory notice is being issued to advise customers that siemens is providing an addendum to the symbia e and e.Cam user manual with specific enhancements to the instructions for collimator change. incidents during collimator change may be avoided by operators properly following specified instructions.

Device

E.CAM SIGNATURE SERIES
  • Modelo / Serial
    Model Catalog: 07333235 (Lot serial: ALL); Model Catalog: 07333284 (Lot serial: ALL); Model Catalog: 10275879 (Lot serial: SN 1012)
  • Descripción del producto
    E.CAM SIGNATURE SERIES;SYMBIA E DUAL HEAD SYSTEM
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC