Events

Retiro De Equipo (Recall) de MEVATRON LINEAR ACCELERATORS

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
    25259
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-06-24
  • 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 became aware of an incident with a linear accelerator oncor where an autosequence was set up with a treatment management system. during the autosequence the gantry collided with the patient's head while moving. the patient received a wound on the head that resulted in skin injuries but no further damage. the user provided a detailed report in which he described that a mistake was made when selecting the beams for autosequence. the user error caused the unintended motion and hence the injury.

Device

MEVATRON LINEAR ACCELERATORS
  • Modelo / Serial
    Model Catalog: 04504200 (Lot serial: 3645); Model Catalog: 01940035 (Lot serial: 3645); Model Catalog: 04504200 (Lot serial: 3641); Model Catalog: 01940035 (Lot serial: 3641); Model Catalog: 04504200 (Lot serial: 3382); Model Catalog: 01940035 (Lot serial: 3382); Model Catalog: 8139789 (Lot serial: 5414); Model Catalog: 01940035 (Lot serial: 3919); Model Catalog: 04504200 (Lot serial: 3919); Model Catalog: 01940035 (Lot serial: 2559); Model Catalog: 04504200 (Lot serial: 2559); Model Catalog: 5857912 (Lot serial: 3799); Model Catalog: 5857912 (Lot serial: 3865); Model Catalog: 7360717 (Lot serial: 5037); Model Catalog: 7360717 (Lot serial: 5041); Model Catalog: 7360717 (Lot serial: 5324)
  • Descripción del producto
    MEVATRON LINEAR ACCELERATORS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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