Events

Retiro De Equipo (Recall) de ONCOR IMPRESSION IMRT PLUS

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
    18564
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-12-10
  • 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
    Siemens has become aware that it is possible for patients or operators to have their fingers trapped and pinched between the table top and the bottom frame of the 550 txt treatment table which is part of the affected systems listed in section 64(a). secondly and unrelated siemens received a report on an incident in which a cable inside of the 550 txt treatment table had been damaged due to contacting a moving part. the resulting short-circuit caused overheating of an electronic circuit board inside the table base.

Device

ONCOR IMPRESSION IMRT PLUS
  • Modelo / Serial
    Model Catalog: 5857912 (Lot serial: 3779); Model Catalog: 7360717 (Lot serial: 5037); Model Catalog: 7360717 (Lot serial: 5041); Model Catalog: 7360717 (Lot serial: 5324); Model Catalog: 8139789 (Lot serial: 5414)
  • Descripción del producto
    ONCOR IMPRESSION IMRT PLUS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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